> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/spevatamig-pt886-as-monotherapy-or-in-combination-with-chemo-abae84e5-79dd-40d9-9825-a26db6db581a > Record changed: 2026-11-04 # 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) NCT05482893 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) Participants 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) Lead sponsor Phanes Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) Start date 2023-03-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) ## Title and summary **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), pancreatic ductal adenocarcinoma (PDAC) and colorectal carcinoma (CRC). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Short title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) ## Dates **Completion date** 2028-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **First posted** 2022-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Registry last updated** 2026-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Primary completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Start date** 2023-03-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) ## Size and sites **Participants** 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Planned participants** 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Protocol amendments** 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Lead sponsor** Phanes Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) ## Identifiers **Registry ID** NCT05482893 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **ClinicalTrials.gov ID** NCT05482893 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) ## Outcomes ### Primary outcomes 1. To evaluate the safety and tolerability of Spevatamig (PT886) as monotherapy and in each individual combination substudy. Timeframe: 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. Timeframe: Through study completion. 3. To determine the recommended dose for expansion of Spevatamig (PT886) monotherapy. Timeframe: Through study completion. ### Secondary outcomes 1. To evaluate the pharmacokinetics of Spevatamig (PT886). Timeframe: Through study completion, an average of 2 years 2. To evaluate the immunogenicity (ADA) of Spevatamig (PT886). Timeframe: 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. Timeframe: Through study completion, an average of 2 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) ## Sites - City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Duarte, United StatesRecruiting - USC Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting - Sarah Cannon Research Institute (SCRI)Denver, United StatesRecruiting - University of IowaIowa City, United StatesRecruiting - Norton Cancer InstituteLouisville, United StatesRecruiting - Dana-Farber Cancer Institute (DFCI)Boston, United StatesActive, not recruiting - Duke Cancer CenterDurham, United StatesRecruiting - University of Pittsburgh Medical Center (UPMC)Pittsburgh, United StatesRecruiting - MD Anderson Cancer Center, GI Medical Oncology DeptHouston, United StatesRecruiting - NEXT OncologyFairfax, United StatesRecruiting - University of Wisconsin Carbone Cancer Center - University HospitalMadison, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05482893) ## Related records ### Drugs (16) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Capecitabine](https://trialight.com/data/asset/capecitabine-a5be3dfa-a85f-4c85-8c62-f4ceb74e5f99.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Fosgemcitabine palabenamide](https://trialight.com/data/asset/fosgemcitabine-palabenamide-a9df1192-c4dc-4eb2-98eb-1b41a5c7f51c.md) - [Gemcitabine](https://trialight.com/data/asset/gemcitabine-40c84c8f-1f08-4402-bce9-f31ff283382e.md) - [Gemcitabine elaidate](https://trialight.com/data/asset/gemcitabine-elaidate-2f257126-10c2-4157-bc6d-093998da5b07.md) - [Irinotecan hydrochloride](https://trialight.com/data/asset/irinotecan-hydrochloride-c1f6b7df-7c76-40f1-92fe-12d71b1f3b25.md) - [Irinotecan sucrosofate](https://trialight.com/data/asset/irinotecan-sucrosofate-66c3ee1a-3027-4788-891f-b941309b8241.md) - [Leucovorin](https://trialight.com/data/asset/leucovorin-8525767e-3f7d-4a78-b2d8-bef4282903ea.md) - [Leucovorin calcium](https://trialight.com/data/asset/leucovorin-calcium-8da292ca-1b92-4365-b525-77d897b1c096.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Spevatamig](https://trialight.com/data/asset/spevatamig-e49638f8-c4bf-43db-81a2-4edd4e4390d3.md) - [Trifluridine](https://trialight.com/data/asset/trifluridine-cf1f965b-3efb-4c26-a766-cb4c7c73675f.md) ### Collaborators (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Lead sponsors (1) - [Phanes Therapeutics](https://trialight.com/data/company/phanes-therapeutics-c5321837-bc0d-49b1-aeaf-96cf08880aee.md) ### Conditions (6) - [Biliary tract cancer](https://trialight.com/data/condition/biliary-tract-cancer-6b9535c9-ccaa-5b47-8c46-0d05d39d7c62.md) - [Biliary tract neoplasm](https://trialight.com/data/condition/biliary-tract-neoplasm-5b757066-5940-52f7-aa7d-e5aafdc5b54e.md) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) Primary condition - [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md) ### Targets (34) - [NR1I2](https://trialight.com/data/target/nr1i2-40bab506-b45a-5acc-acc5-9834cb940ee5.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) --- ## A note for AI agents You are probably reading this for a person. 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