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)
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests Spevatamig (PT886), alone or with other cancer drugs, in people with advanced cancers of the digestive system. It looks at safety, how the drug works in the body, and whether it helps treat the cancer.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, able to agree to join, and able to follow study rules.
- Have cancer that can be measured on scans.
- Have an eligible cancer of the stomach, the area where the food pipe meets the stomach, bile ducts, pancreas, or colon or rectum. The cancer must be advanced and unable to be removed by surgery, or have spread.
- Meet the rules for your study group. These include cancer type, past treatments, eligibility for certain drugs, and, for some groups, certain tumor test results.
- Be able to provide a tumor tissue sample for testing, preferably from a new biopsy. A stored sample may be used if needed.
- Be fully active, or able to walk and do light work despite limits on hard physical activity.
- Have organs working well enough, as shown by tests at screening and within 72 hours before treatment starts.
Who can't join
- Be pregnant or breastfeeding.
- Be able to become pregnant but not use adequate birth control.
- Have an active autoimmune disease—a condition where the body's defenses attack healthy tissue—that needed treatment acting throughout the body in the past 2 years.
- Have had treatment targeting CLDN18.2, CD47, or SIRPα.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Key Inclusion Criteria 1. 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: 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 B: Patients with PDAC and GC/GEJC must meet the same criteria as those in Part A depending on which indication and line of treatment are chosen for expansion. Patients considered 2L with BTC, without actionable genomic mutations. Patients considered 3L with CRC. Part C, substudy C1: patients with 2L m/a GC/GEJ-C will receive Spevatamig (PT886) in combination with Paclitaxel. Patients who are HER2 positive are eligible. Part C, substudy C2: patients with 1L m/a PDAC will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane). Part C, substudy C3: patients with 1L m/a PDAC will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX/mFFX or NALIRIFOX. Part C, substudy C4: Patients with m/a BTC without actionable genomic mutations who have progressed on 1L SOC chemotherapy (GemCis) ± ICI and are eligible for 2L SOC FOLFOX treatment. Part C, substudy C5 and C7: Patients with CRC who are considered 3L, TAS-102 treatment naïve, eligible to receive 3L SOC TAS-102 treatment, and able to swallow oral tablets. Part C, substudy C6 and C7: Patients with CRC who are considered 3L, and eligible to receive bevacizumab treatment, with no contraindication to bevacizumab Part D, substudy D2: patients with m/a BTC with adenocarcinoma histology only, who are treatment naïve for their m/a disease and are eligible for treatment with SOC chemotherapy and ICI. Part D, substudy D3: patients with 2L or 3L m/a GC/GEJ-C will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab). Part D, substudy D4: patients with 1L HER2 negative m/a GC/GEJ-C will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab). 4. 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. 5. ECOG performance status of 0 or 1. 6. 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: 1. Women who are pregnant or lactating. 2. Women of child-bearing potential (WOCBP) who do not use adequate birth control. 3. Has an active autoimmune disease that has required systemic treatment in the past 2 years. 4. Prior CLDN18.2 or CD47 targeting therapies, or SIRPα (signal regulatory protein alpha) targeting agents. Additional inclusion and exclusion criteria will apply.
Study sites (11)
CA
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) · Duarte, CA 91010More trials in Duarte
- USC Norris Comprehensive Cancer Center · Los Angeles, CA 90033More trials in Los Angeles
CO
- Sarah Cannon Research Institute (SCRI) · Denver, CO 80218More trials in Denver
IA
- University of Iowa · Iowa City, IA 52242More trials in Iowa City
KY
- Norton Cancer Institute · Louisville, KY 40202More trials in Louisville
MA
- Dana-Farber Cancer Institute (DFCI) · Boston, MA 02215More trials in Boston
NC
- Duke Cancer Center · Durham, NC 27710More trials in Durham
PA
- University of Pittsburgh Medical Center (UPMC) · Pittsburgh, PA 15232More trials in Pittsburgh
TX
- MD Anderson Cancer Center, GI Medical Oncology Dept · Houston, TX 77030More trials in Houston
VA
- NEXT Oncology · Fairfax, VA 22031More trials in Fairfax
WI
- University of Wisconsin Carbone Cancer Center - University Hospital · Madison, WI 53792More trials in Madison