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OncoMatch/Clinical Trials/NCT05482893

Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or Targeted Therapy and/or ICI, for the Treatment of Patients With Advanced Gastrointestinal Cancers, Including Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)

Official title: A Phase 1/2, Open-Label, Dose Escalation and Expansion Study With PT886 Followed by a Multi-cohorT Study in Patients With Advanced Gastrointestinal Cancers, Including GastrIc, Gastroesophageal JuNction, Pancreatic Ductal or Biliary Tract AdEnocarcinomas of PT886, in Combination With ChemotherApy, Targeted Therapy, and/or an Immune ChecKpoint Inhibitor. The TWINPEAK Study

Is NCT05482893 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments for gastric or gastroesophageal junction adenocarcinoma.

Phase 1/2RecruitingPhanes TherapeuticsNCT05482893Data as of Oct 2026

Treatment: Spevatamig (PT886) · Paclitaxel · Gemcitabine · Abraxane · KEYTRUDA® (pembrolizumab) · FOLFOX · CAPOX · FOLFIRINOX · TAS 102 · Bevacizumab · Gemcitabine Combined With Cisplatin · NALIRIFOX — This is a first-in-human, Phase 1/2, open-label, dose escalation and dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Spevatamig (PT886). Patients with the following tumor types will be eligible for screening: unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, biliary tract carcinoma (BTC), pancreatic ductal adenocarcinoma (PDAC) and colorectal carcinoma (CRC).

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Extracted eligibility criteria

Treatments studied

Immunotherapy

KEYTRUDA® (pembrolizumab)

Targeted therapy

Bevacizumab

Chemotherapy

PaclitaxelGemcitabineAbraxaneGemcitabine Combined With Cisplatin

Other

Spevatamig (PT886)FOLFOXCAPOXFOLFIRINOXTAS 102NALIRIFOX

Cancer type

Esophageal Carcinoma

Gastric Cancer

Pancreatic Cancer

Cholangiocarcinoma

Colorectal Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: CLDN18.2-targeted therapy

Prior CLDN18.2 ... targeting therapies

Cannot have received: CD47-targeted therapy

Prior ... CD47 targeting therapies

Cannot have received: SIRPA-targeted therapy

Prior ... SIRPα (signal regulatory protein alpha) targeting agents

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center) · Duarte, California
  • USC Norris Comprehensive Cancer Center · Los Angeles, California
  • Sarah Cannon Research Institute (SCRI) · Denver, Colorado
  • University of Iowa · Iowa City, Iowa
  • Norton Cancer Institute · Louisville, Kentucky

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05482893 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior CLDN18.2-targeted therapy, CD47-targeted therapy, SIRPA-targeted therapy disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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