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NCT Number: NCT05482893

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

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) and pancreatic ductal adenocarcinoma (PDAC).

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Key information

Conditions

Gastric or Gastroesophageal Junction Adenocarcinoma Biliary Tract Cancer (BTC) Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site Pancreatic Ductal Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria

  • 18 years or older and able to sign informed consent and comply with the protocol.
  • Measurable disease as defined by RECIST V1.1 criteria for solid tumors.
  • 3. Part A and Part B: Histologically or cytologically confirmed unresectable advanced or metastatic solid gastric, gastroesophageal junction (GEJ), biliary tract or pancreatic carcinomas previously treated for advanced (metastatic or unresectable) disease or for which treatment is not available or not tolerated.

Part C, substudy C1: 2L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with Paclitaxel. Patients who are HER2 positive are eligible.

Part C, substudy C2: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane).

Part C, substudy C3: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX/mFFX.

Part C, substudy C4: Patients with m/a BTC who have progressed on 1L SOC chemotherapy (GemCis) ± ICI and are eligible for 2L SOC FOLFOX treatment.

Part D, substudy D3: 2L or 3L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab).

Part D, substudy D4: 1L HER2 negative m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab).

  • Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably fresh biopsy or if not possible, archival tissue) to be assessed for CLDN18.2 expression and other biomarkers.
  • ECOG performance status of 0 or 1.
  • Adequate organ function confirmed at screening and within 72 hours of initiating treatment.

Key Exclusion Criteria

Patients are excluded from the study if any of the following criteria apply:

  • Women who are pregnant or lactating.
  • Women of child-bearing potential (WOCBP) who do not use adequate birth control.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years.
  • Prior CLDN18.2 or CD47 targeting therapies, or SIRPα (signal regulatory protein alpha) targeting agents.

Additional inclusion and exclusion criteria will apply.

Treatment and study plan

Spevatamig (PT886)

Drug

Spevatamig (PT886) monotherapy, a novel bispecific antibody that targets Claudin 18.2 and CD47.

paclitaxel

Drug

Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudy C1

Gemcitabine

Drug

Chemotherapy as a combination partner to Abraxane and Spevatamig (PT886) in Part C: substudy C2

Abraxane

Drug

Chemotherapy as a combination partner to Gemcitabine and Spevatamig (PT886) in Part C: substudy C2

KEYTRUDA® (pembrolizumab)

Drug

Immune checkpoint inhibitor as a combination partner to Spevatamig (PT886) in Part D.

FOLFOX

Drug

Chemotherapy as a combination partner to Spevatamig (PT886) and KEYTRUDA® (pembrolizumab, Part D only)

Capox

Drug

Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886)

Folfirinox

Drug

Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudy C3

Primary outcomes

  1. To evaluate the safety and tolerability of Spevatamig (PT886) as monotherapy and in each individual combination substudy.

    Time frame: Through study completion, an average of 2 years

  2. To evaluate anti-tumor activity of PT886 as assessed by ORR, in Spevatamig (PT886) monotherapy and in each combination substudy.

    Time frame: Through study completion.

  3. To determine the recommended dose for expansion of Spevatamig (PT886) monotherapy.

    Time frame: Through study completion.

Secondary outcomes

  1. To evaluate the pharmacokinetics of Spevatamig (PT886).

    Time frame: Through study completion, an average of 2 years

  2. To evaluate the immunogenicity (ADA) of Spevatamig (PT886).

    Time frame: Through study completion, an average of 2 years

  3. To evaluate anti-tumor activity as assessed by additional measures other than ORR, in Spevatamig (PT886) monotherapy and in each combination substudy.

    Time frame: Through study completion, an average of 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Phanes Therapeutics

CONTACT

[email protected]

858-766-0852

Sponsors and collaborators

Lead sponsor

Phanes Therapeutics

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Phase 1/2, Open-Label, Dose Escalation and Expansion Study With PT886 (Spevatamig) Followed by a Multi-cohorT Study in Patients With Advanced GastrIc, Gastroesophageal JuNction, Pancreatic Ductal or Biliary Tract AdEnocarcinomas of PT886, in Combination With ChemotherApy, and/or an Immune ChecKpoint Inhibitor. The TWINPEAK Study

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 1, 2022
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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