Trial Watch No. 19

▸ Oncology

Phase 3 · Oncology — second-line RAS/BRAF WT mCRC

Petosemtamab + FOLFIRI/mFOLFOX6 vs. Cetuximab/Bevacizumab + Chemo in Second-Line RAS/BRAF Wild-Type mCRC

Sponsor: Genmab

Phase / Status / Enrollment: Phase 3, randomized, open-label · Recruiting · 600 participants

Timeline: Start October 7, 2026 · Primary completion March 2029

Mechanism: Petosemtamab (MCLA-158) is Genmab's EGFRxLGR5 bispecific antibody — the next-generation EGFR-targeting mechanism designed to overcome cetuximab/panitumumab resistance by also engaging LGR5+ cancer stem cells. Tested in second-line RAS and BRAF wild-type mCRC vs. standard-of-care EGFR mAb or bevacizumab combinations.

Why it matters: This 600-participant randomized Phase 3 extends Genmab's EGFRxLGR5 strategy into second-line RAS/BRAF wild-type metastatic colorectal cancer. The direct comparison against established cetuximab- or bevacizumab-based regimens will test whether dual EGFR/LGR5 targeting can improve on current biologic standards.

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07775287

Veeva exact trial page: https://ctv.veeva.com/study/study-of-petosemtamab-plus-chemotherapy-versus-cetuximab-or-bevacizumab-plus-chemotherapy-in-ras-and

Phase 3 · Oncology — first-line ovarian maintenance

Starstone-Ovarian 301 · BG-C9074 + Bevacizumab vs. Bevacizumab Maintenance in First-Line Ovarian Cancer

Sponsor: BeOne Medicines (formerly BeiGene)

Phase / Status / Enrollment: Phase 3, randomized, open-label · Not yet recruiting · 600 participants

Timeline: Start October 2026 · Primary completion November 2029

Mechanism: BG-C9074 is BeOne Medicines' B7-H4-targeting antibody-drug conjugate with a topoisomerase I payload. Starstone-Ovarian 301 tests BG-C9074 plus bevacizumab against bevacizumab alone as first-line maintenance after platinum-based chemotherapy plus bevacizumab.

Why it matters: The study moves BG-C9074 from early clinical development into a 600-participant first-line ovarian maintenance Phase 3. It tests whether adding a B7-H4 ADC to bevacizumab can improve maintenance therapy for patients who have not progressed after first-line platinum chemotherapy plus bevacizumab.

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07811271

Veeva exact trial page: https://ctv.veeva.com/study/efficacy-and-safety-of-bg-c9074-with-bevacizumab-compared-with-bevacizumab-in-adults-with-ovarian-f

Phase 3 · Oncology — first-line extrapulmonary NEC

ZG005 (PD-1/TIGIT Bispecific) + Etoposide/Cisplatin vs. EP in First-Line Advanced Neuroendocrine Carcinoma

Sponsor: Suzhou Zelgen Biopharmaceuticals Co., Ltd.

Phase / Status / Enrollment: Phase 3, randomized, double-blind, controlled · Not yet recruiting · 440 participants

Timeline: Start October 2026 · Primary completion October 2031

Mechanism: ZG005 is Zelgen's PD-1/TIGIT bispecific antibody combined with etoposide + cisplatin chemotherapy as first-line treatment for advanced neuroendocrine carcinoma (NEC) — a historically chemo-only indication with limited IO options.

Why it matters: TIGIT bispecifics have been the "next PD-1" bet across the industry for 5+ years — Roche tiragolumab, BMS BMS-986502, Merck vibostolimab all pursued the combination. ZG005 in NEC is the first PD-1/TIGIT bispecific Phase 3 in extrapulmonary neuroendocrine carcinoma — an orphan indication where even modest IO benefit would reshape standard of care.

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07833839

Veeva exact trial page: https://ctv.veeva.com/study/zg005-plus-etoposide-and-cisplatin-vs-etoposide-and-cisplatin-as-first-line-treatment-for-advanced

Phase 3 · Oncology — pediatric osteosarcoma

FOSTER Evolving Study Platform · Cabozantinib in Osteosarcoma

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Phase / Status / Enrollment: Phase 3, platform trial · Recruiting · 530 participants · 77 sites

Timeline: Start October 2026 · Primary completion January 2036

Mechanism: Cabozantinib (Cometriq/Cabometyx, Exelixis's multi-kinase inhibitor approved in multiple adult cancers) 40 mg/m²/day for 12 cycles in pediatric and adolescent/young adult patients with osteosarcoma. FOSTER is a multi-arm, multi-stage adaptive platform.

Why it matters: A large international osteosarcoma platform — 530 participants across 77 sites. Osteosarcoma remains a pediatric cancer with limited treatment advancement since high-dose methotrexate/doxorubicin/cisplatin (MAP) became standard in the 1980s. Platform trial design accelerates testing of multiple experimental arms vs. shared controls. Positive readout would establish the first targeted therapy as adjunct standard-of-care in pediatric osteosarcoma.

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07871864

Veeva exact trial page: https://ctv.veeva.com/study/fight-osteosarcoma-through-european-research-evolving-study-platform-from-diagnosis-to-relapse

Phase 3 · Oncology — second-line metastatic PDAC

YL201 (Tambotatug Pelitecan) vs. Liposomal Irinotecan + 5-FU/Leucovorin in Metastatic Pancreatic Cancer

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Phase / Status / Enrollment: Phase 3, randomized, controlled · Not yet recruiting · 320 participants

Timeline: Start October 2026 · Primary completion January 2029

Mechanism: Tambotatug pelitecan (YL201) is MediLink's B7-H3-targeting antibody-drug conjugate with a topoisomerase I payload. Tested in metastatic pancreatic ductal adenocarcinoma patients who have failed gemcitabine-based therapy, vs. the second-line standard liposomal irinotecan + 5-FU/leucovorin.

Why it matters: This randomized Phase 3 brings MediLink's B7-H3 ADC into second-line metastatic pancreatic cancer against liposomal irinotecan plus 5-FU/leucovorin. It extends YL201's pivotal development into a tumor type with limited options after gemcitabine-based therapy.

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07803783

Veeva exact trial page: https://ctv.veeva.com/study/a-study-to-compare-the-efficacy-and-safety-of-yl201-with-standard-chemotherapy-in-patients-with-meta

▸ Transplant & Cardiometabolic

Phase 3 · Transplant — anti-CD40L revival · MEGA-SCALE

Tegoprubart vs. Tacrolimus in De Novo Adult Kidney Transplantation

Sponsor: Eledon Pharmaceuticals

Phase / Status / Enrollment: Phase 3, randomized, active-controlled, open-label · Not yet recruiting · 620 participants

Timeline: Start October 2026 · Primary completion March 2029

Mechanism: Tegoprubart is Eledon's silent-Fc anti-CD40 ligand (CD154) monoclonal antibody. CD40L inhibition prevents T-cell and B-cell co-stimulation while sparing the nephrotoxicity of calcineurin inhibitors. Silent Fc design avoids FcγR engagement that caused thrombosis with hu5C8 in the 1990s. Tested head-to-head against tacrolimus in de novo kidney transplant.

Why it matters: Anti-CD40L was abandoned in 1999 after hu5C8 caused thromboembolic events in SLE and transplant trials. Tegoprubart is the first next-generation anti-CD40L in Phase 3 — resurrecting a mechanism that was the single most promising transplant immunosuppressant of its decade. If tegoprubart beats tacrolimus, calcineurin inhibitors — used in 95%+ of transplants for 25+ years and the leading cause of chronic allograft nephropathy — face a long-awaited successor. Franchise-defining for both transplant and the broader CD40L class (which Eledon is also testing in ALS and T1D).

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07835581

Veeva exact trial page: https://ctv.veeva.com/study/phase-3-randomized-study-of-tegoprubart-efficacy-and-safety-compared-with-tacrolimus-in-kidney-trans

Phase 3 · Cardiometabolic — obesity + OSA on PAP (UBT franchise)

UNISHAPE-OSA-2 · UBT251 in Obese Patients With Moderate-to-Severe OSA on PAP Therapy

Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

Phase / Status / Enrollment: Phase 3, randomized, double-blind, placebo-controlled · Not yet recruiting · 150 participants

Timeline: Start October 10, 2026 · Primary completion March 2029

Mechanism: Companion to UNISHAPE-OSA-1 (Ed 18). UBT251 (GLP-1/glucagon/GIP triple agonist) in obese patients with moderate-to-severe OSA who ARE on positive airway pressure (PAP) therapy. Tests the drug's ability to reduce OSA severity on top of current standard of care.

Why it matters: UBT251's fifth Phase 3 across KITSA tracking: T2D on metformin (UNIGUIDE-2, Ed 14), obesity dose-finding (Ed 12), first-line T2D (UNIGUIDE-1, Ed 15), OSA without PAP (UNISHAPE-OSA-1, Ed 18), and now OSA on PAP. The fastest and broadest Chinese biotech obesity program buildout. The on-PAP population establishes OSA as a dual-endpoint market — both as a weight loss indication and as a PAP-sparing therapy.

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07806851

Veeva exact trial page: https://ctv.veeva.com/study/ubt251-injection-phase-iii-study-osa-pap

Phase 3 · Cardiometabolic — diabetic macular edema

GOBI · OLN324 vs. Aflibercept in Diabetic Macular Edema

Sponsor: Ollin Biosciences, Inc.

Phase / Status / Enrollment: Phase 3, randomized, double-masked, active-controlled · Not yet recruiting · 450 participants

Timeline: Start October 15, 2026 · Primary completion December 2028

Mechanism: OLN324 is Ollin Biosciences' investigational intravitreal biologic for DME, tested head-to-head against aflibercept (Eylea, Regeneron's $9B+ anti-VEGF). GOBI is one of two companion DME Ph3s (ATACAMA is the second).

Why it matters: GOBI puts OLN324 directly against aflibercept in a 450-participant Phase 3 in diabetic macular edema. The active-comparator design creates a clear test against an established retinal standard rather than relying on placebo-controlled efficacy alone.

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07842016

Veeva exact trial page: https://ctv.veeva.com/study/phase-3-study-of-intravitreal-oln324-in-adults-with-diabetic-macular-edema-dme-oln324-cp03

Phase 3 · Cardiometabolic — obesity (Pfizer China)

Once-Monthly PF-08653944 (Berobenatide) vs. Placebo in Chinese Adults With Overweight or Obesity

Sponsor: Pfizer

Phase / Status / Enrollment: Phase 3, randomized, double-blind, placebo-controlled · Not yet recruiting · 432 participants

Timeline: Start October 15, 2026 · Primary completion June 2028

Mechanism: Pfizer's berobenatide (PF-08653944) — a once-monthly injectable obesity asset — tested vs. placebo specifically in Chinese adults with overweight or obesity.

Why it matters: Pfizer's obesity program now runs 4+ Phase 3s in Asian-specific populations: VESPER-JM (Japan monthly, Ed 16), VESPER-JW (Japan weekly, Ed 16), VESPER-OSA 1 (OSA, Ed 18), and now Chinese obesity. The Asia-specific franchise strategy signals Pfizer's conviction that once-monthly dosing with Berobenatide is the differentiator — and that Asian regulatory pathways are a priority for the obesity category after multiple Western competitors reached market.

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07874633

Veeva exact trial page: https://ctv.veeva.com/study/a-study-to-learn-about-the-study-medicine-called-pf-08653944-taken-once-monthly-compared-to-placebo

Phase 3 · Neurology/Psychiatry — ulotaront GAD OLE · MEGA-SCALE

SEP-363856 (Ulotaront) Long-Term OLE for Generalized Anxiety Disorder

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Phase / Status / Enrollment: Phase 3, open-label extension · Not yet recruiting · 1,120 participants

Timeline: Start October 6, 2026 · Primary completion May 2029

Mechanism: Long-term open-label extension of ulotaront (SEP-363856, TAAR1 agonist) in adults with generalized anxiety disorder. Parent trial launched in Ed 15 (Otsuka's fixed-dose Ph3 in GAD).

Why it matters: The 1,120-participant extension is designed to build the longer-term safety and tolerability dataset for ulotaront in generalized anxiety disorder. It follows Otsuka's pivotal GAD program and tests whether the TAAR1-based approach can support chronic use beyond the short-term efficacy studies.

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07786454

Veeva exact trial page: https://ctv.veeva.com/study/a-trial-of-the-safety-and-tolerability-of-sep-363856-in-adults-with-generalized-anxiety-disorder

▸ Immunology & Respiratory

Phase 3 · Immunology — cutaneous lupus LTE

Elowen-LTE · Enpatoran Long-Term Extension in Active Cutaneous Lupus With or Without SLE

Sponsor: EMD Serono Research & Development Institute, Inc.

Phase / Status / Enrollment: Phase 3, single-arm, open-label extension · Not yet recruiting · 404 participants

Timeline: Start October 15, 2026 · Primary completion September 2031

Mechanism: Enpatoran is EMD Serono's oral TLR7/8 antagonist for active cutaneous manifestations of lupus erythematosus. Elowen-LTE provides long-term safety and efficacy data in patients continuing from the parent Elowen Phase 3.

Why it matters: First TLR7/8 antagonist to reach long-term extension in cutaneous lupus. TLR7/8 is the pathway driving Type I interferon signaling — upstream of the IFN-α mechanism that anifrolumab blocks (AZ, approved for SLE). Enpatoran takes the oral small-molecule approach, which — if durability holds — delivers patient access and compliance advantages over injectables.

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07840287

Veeva exact trial page: https://ctv.veeva.com/study/a-long-term-extension-lte-study-of-enpatoran-in-cutaneous-manifestations-of-lupus-with-or-without

Phase 1/2 · Immunology — iPSC NK autoimmune

FT839 · iPSC-Derived Allogeneic NK Cell Therapy in SLE, SSc, Myositis, RA, ANCA Vasculitis

Sponsor: Fate Therapeutics

Phase / Status / Enrollment: Phase 1/2, dose escalation and expansion · Recruiting · 446 participants

Timeline: Start October 2026 · Primary completion October 2028

Mechanism: FT839 is Fate Therapeutics' off-the-shelf, iPSC-derived dual-CAR T-cell therapy engineered to co-target CD19 and CD38. The Phase 1/2 study spans SLE, systemic sclerosis, idiopathic inflammatory myositis, rheumatoid arthritis, and ANCA-associated vasculitis.

Why it matters: Autoimmune cell therapy continues to diversify within CAR-T. FT839 combines an off-the-shelf iPSC manufacturing platform with dual CD19/CD38 targeting to address multiple pathogenic immune-cell compartments. The 446-participant Phase 1/2 program spans five autoimmune disease groups and tests the platform at broad basket-trial scale.

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07800871

Veeva exact trial page: https://ctv.veeva.com/study/ft839-in-autoimmune-diseases

Phase 3 · Respiratory — autologous stem cell COPD

REGEND001 Autologous Cell Therapy vs. Placebo in Moderate-to-Severe COPD

Sponsor: Regend Therapeutics

Phase / Status / Enrollment: Phase 3, randomized, blinded, placebo-controlled confirmatory · Not yet recruiting · 102 participants

Timeline: Start October 2026 · Primary completion September 2028

Mechanism: REGEND001 is Regend Therapeutics's autologous bronchial basal cell therapy — patient's own airway progenitor cells harvested, expanded, and reinfused into damaged lung tissue to regenerate alveolar structure.

Why it matters: First Phase 3 of a regenerative stem cell therapy in COPD. Current COPD therapy only slows decline — none regenerate lung tissue. If REGEND001 delivers measurable alveolar regeneration, it establishes the first disease-modifying rather than symptom-managing COPD therapy. Follows GSK PERSIST (Ed 16, 2,986 pts across COPD/asthma/CRSwNP), Sanofi Lunsekimig (Ed 17 OLE, 1,508 pts), Pfizer Tilrekimig (Ed 18 OLE, 1,360 pts) — the respiratory Type 2 franchise now has its regenerative counterpart.

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07828353

Veeva exact trial page: https://ctv.veeva.com/study/a-clinical-study-of-regend001-for-the-treatment-of-chronic-obstructive-pulmonary-disease-copd

▸ Advanced Modalities — Gene Therapy & CAR-T

Phase 1/2 · Adv. Modalities — AAV glucokinase gene therapy for T1D

VV-14300 · AAV-Mediated Glucokinase Gene Therapy in Long-Standing Type 1 Diabetes

Sponsor: Kriya Therapeutics, Inc.

Phase / Status / Enrollment: Phase 1/2, first-in-human, dose escalation and expansion · Recruiting · 29 participants · 2 sites

Timeline: Start October 2026 · Primary completion November 2028

Mechanism: VV-14300 is Kriya Therapeutics' AAV vector-mediated glucokinase gene therapy. It is administered by ultrasound-guided intramuscular injection and is being evaluated in adults with long-standing Type 1 diabetes whose glycemic control remains suboptimal despite automated insulin delivery.

Why it matters: RELIEVE brings AAV-mediated glucokinase delivery into a first-in-human Type 1 diabetes study. The 29-participant program tests whether a one-time genetic intervention delivered to muscle can improve glucose control alongside existing automated insulin delivery rather than replacing insulin therapy outright.

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07831798

Veeva exact trial page: https://ctv.veeva.com/study/vv-14300-for-the-treatment-of-type-1-diabetes

Phase 2b/3 · Neurology — ALS

Tazbentetol vs. Placebo in Amyotrophic Lateral Sclerosis

Sponsor: Spinogenix

Phase / Status / Enrollment: Phase 2b/3, randomized, double-blind, placebo-controlled · Not yet recruiting · 430 participants

Timeline: Start October 1, 2026 · Primary completion December 2027

Mechanism: Tazbentetol (SPG302) is Spinogenix's first-in-class once-daily oral synaptic regeneration drug. Preclinical data showed restoration of excitatory synapses in motor neurons — a mechanism distinct from the anti-glutamatergic/anti-oxidant approach of riluzole and edaravone, the only approved ALS drugs.

Why it matters: ALS remains an area of major unmet need despite several approved therapies and repeated late-stage development failures. This 430-participant adaptive Phase 2b/3 tests a synaptic-regeneration strategy that is mechanistically distinct from established ALS treatments.

Verified Sources

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07325591

Veeva exact trial page: https://ctv.veeva.com/study/efficacy-and-safety-of-tazbentetol-in-als-participants

Signal Convergence

Five patterns across the October 1–15 window

1. Anti-CD40L returns to Phase 3 in transplant after a 25-year absence. Eledon's Tegoprubart vs. tacrolimus (620 pts) is the first next-generation anti-CD40L mAb to reach a transplant pivotal. Hu5C8 was abandoned in 1999 after thrombotic complications; tegoprubart's silent-Fc design avoids FcγR engagement. If positive, calcineurin inhibitors — the standard of care in 95%+ of transplants for 25+ years, and the leading cause of chronic allograft nephropathy — face a long-awaited successor.

2. Gene therapy enters Type 1 diabetes. Kriya's 29-participant RELIEVE study brings AAV-mediated glucokinase delivery into long-standing T1D. The program expands the advanced-modality landscape beyond oncology and rare monogenic disease into a common autoimmune metabolic condition.

3. Cell-therapy modalities continue to diversify. Fate's FT839 is an off-the-shelf iPSC-derived dual CD19/CD38 CAR T-cell therapy spanning five autoimmune disease groups, while REGEND001 tests autologous airway basal-cell therapy in Phase 3 COPD.

4. Osteosarcoma gets a large adaptive European platform. FOSTER is enrolling 530 participants across 77 sites and is designed to test therapeutic strategies from diagnosis through relapse, including a randomized cabozantinib component.

5. Berobenatide expands geographically. Pfizer's 432-participant China Phase 3 adds another late-stage obesity study centered on once-monthly dosing and extends the program's regional development footprint.

Underlying truth: late-stage clinical development is broadening across mechanisms that were previously difficult to operationalize. CD40L blockade, AAV gene therapy, off-the-shelf dual-CAR T cells, regenerative cell therapy, and next-generation ADCs are all moving through increasingly ambitious clinical programs.

Continue Tracking

Trial Watch is KITSA's clinical intelligence layer.

Edition 20 (October 16–31, 2026) drops on October 31.

On Verification

Every trial in this edition now carries two direct, trial-specific sources: the canonical ClinicalTrials.gov record and an exact Veeva Clinical Trials study page for the same NCT ID. WHO ICTRP query links, generic sponsor homepages, pipeline pages, and “search this term” instructions have been removed. Trial links and key registry fields were rechecked on October 19, 2026. Where ClinicalTrials.gov publishes the start date only at month precision, this edition preserves “October 2026” rather than inventing a day-level date.