Trials / Recruiting
RecruitingNCT05482893
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)
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 258 (estimated)
- Sponsor
- Phanes Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
- Gastric or Gastroesophageal Junction Adenocarcinoma
- Pancreatic Ductal Adenocarcinoma
- Biliary Tract Cancer (BTC)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Spevatamig (PT886) | Spevatamig (PT886) monotherapy, a novel bispecific antibody that targets Claudin 18.2 and CD47. |
| DRUG | Paclitaxel | Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: Cohort C1 |
| DRUG | Gemcitabine | Chemotherapy as a combination partner to Abraxane and Spevatamig (PT886) in Part C: Cohort C2 |
| DRUG | Abraxane | Chemotherapy as a combination partner to Gemcitabine and Spevatamig (PT886) in Part C: Cohort C2 |
| DRUG | KEYTRUDA® (pembrolizumab) | Immune checkpoint inhibitor as a combination partner to Spevatamig (PT886) in Part D: Cohort D2, D3 and D4. |
| DRUG | Oxaliplatin | Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4 |
| DRUG | Leucovorin | Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4 |
| DRUG | Fluorouracil | Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4 |
| DRUG | Capecitabine | Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4 |
| DRUG | FOLFIRINOX | Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: Cohort C3 |
Timeline
- Start date
- 2023-03-15
- Primary completion
- 2027-12-01
- Completion
- 2028-04-01
- First posted
- 2022-08-01
- Last updated
- 2025-11-04
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05482893. Inclusion in this directory is not an endorsement.