NCT05482893 · Phanes Therapeutics
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)
What this study is about
This is a first-in-human, Phase 1/2, where both patients and doctors know the treatment given, gradually increasing doses and dose expansion and combination study designed to evaluate the safety, tolerability, how the drug moves through the body, how the drug affects the body, and preliminary effectiveness of Spevatamig (PT886).
View original scientific description
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).
Interventions
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: substudy C1
DRUG
Gemcitabine
Chemotherapy as a combination partner to Abraxane and Spevatamig (PT886) in Part C: substudy C2
DRUG
Abraxane
Chemotherapy as a combination partner to Gemcitabine and Spevatamig (PT886) in Part C: substudy C2
DRUG
KEYTRUDA® (pembrolizumab)
Immune checkpoint inhibitor as a combination partner to Spevatamig (PT886) in Part D.
DRUG
FOLFOX
Chemotherapy as a combination partner to Spevatamig (PT886) and KEYTRUDA® (pembrolizumab, Part D only)
DRUG
CAPOX
Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886)
DRUG
FOLFIRINOX
Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudy C3
Primary outcome measures
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
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.
To determine the recommended dose for expansion of Spevatamig (PT886) monotherapy.
Time frame: Through study completion.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 years or older and able to sign informed consent and comply with the protocol. 2. Measurable disease as defined by RECIST V1.1 criteria for solid tumors. 3. 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, Cohort 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, Cohort C2: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane). Part C, Cohort C3: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX/mFFX. Cohort C4: Patients with m/a BTC who have progressed on 1L SOC chem
Where
- Duarte, California
- Los Angeles, California
- Denver, Colorado
- Iowa City, Iowa
- Louisville, Kentucky
- Boston, Massachusetts
- Durham, North Carolina
- Pittsburgh, Pennsylvania
- Houston, Texas
- Fairfax, Virginia
- Madison, Wisconsin
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations