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)

Part of paid clinical trials in Duarte, California.

Sponsor
Phanes Therapeutics
Study ID
NCT05482893
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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: Cohort C1
  • Gemcitabine — DRUG
    Chemotherapy as a combination partner to Abraxane and Spevatamig (PT886) in Part C: Cohort C2
  • Abraxane — DRUG
    Chemotherapy as a combination partner to Gemcitabine and Spevatamig (PT886) in Part C: Cohort C2
  • KEYTRUDA® (pembrolizumab) — DRUG
    Immune checkpoint inhibitor as a combination partner to Spevatamig (PT886) in Part D: Cohort D2, D3 and D4.
  • Oxaliplatin — DRUG
    Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4
  • Leucovorin — DRUG
    Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4
  • Fluorouracil — DRUG
    Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4
  • Capecitabine — DRUG
    Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4
  • FOLFIRINOX — DRUG
    Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: Cohort C3

Study Details

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).

Key Dates

Start date
Mar 15, 2023
Status verified
Jun 2025
Primary completion
Dec 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
258 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    An accelerated titration design will be employed for early dose levels, followed by the standard 3+3 design at higher dose levels.
  • Experimental: Dose Expansion
    Two dose levels will be explored; the recommended dose for expansion (RDE) from Part A, and another dose level.
  • Experimental: Combination Expansion with Chemotherapy
    Part C, Cohort C1: 2L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with Paclitaxel. 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. Part C, Cohort C4: 2L BTC patients will receive PT886 in combination with SOC chemotherapy mFOLFOX6. Cohort C5, 1L HER2 negative PD-L1 CPS \< 1 GC/GEJC patients will receive PT886 in combination with SOC chemotherapy mFOLFOX6 or CAPOX.
  • Experimental: Combination Expansion with KEYTRUDA® (pembrolizumab)
    Part D, Cohort D2: Patients with m/a GC/GEJ-C, that have progressed under 1L SOC chemotherapy, and zolbetuximab, will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab). Part D, Cohort D3: 2L or 3L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab). Part D, Cohort D4: 1L HER2 negative m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab).

Primary Outcome Measure

To determine the dose-limiting toxicity (DLT) of Spevatamig (PT886). [ Time Frame: Through study completion. ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)DuarteCalifornia91010-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Sarah Cannon Research Institute (SCRI)DenverColorado80218-
University of IowaIowa CityIowa52242-
Norton Cancer InstituteLouisvilleKentucky40202-
Dana-Farber Cancer Institute (DFCI)BostonMassachusetts02215-
Duke Cancer CenterDurhamNorth Carolina27710-
University of Pittsburgh Medical Center (UPMC)PittsburghPennsylvania15232-
MD Anderson Cancer Center, GI Medical Oncology DeptHoustonTexas77030-
NEXT OncologyFairfaxVirginia22031-
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792-

Find similar trials in Duarte, CA

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City of Hope (City of Hope National Medical Center, City of Hope Medical Center)· Duarte, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CASarah Cannon Research Institute (SCRI)· Denver, COUniversity of Iowa· Iowa City, IANorton Cancer Institute· Louisville, KYDana-Farber Cancer Institute (DFCI)· Boston, MA

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