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: substudy C1
  • Gemcitabine — DRUG
    Chemotherapy as a combination partner to Abraxane and Spevatamig (PT886) in Part C: substudy C2
  • Abraxane — DRUG
    Chemotherapy as a combination partner to Gemcitabine and Spevatamig (PT886) in Part C: substudy C2
  • KEYTRUDA® (pembrolizumab) — DRUG
    Immune checkpoint inhibitor as a combination partner to Spevatamig (PT886) in Part D.
  • FOLFOX — DRUG
    Chemotherapy as a combination partner to Spevatamig (PT886) and KEYTRUDA® (pembrolizumab, Part D only)
  • CAPOX — DRUG
    Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886)
  • FOLFIRINOX — DRUG
    Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudy 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

First listed
Aug 1, 2022
Start date
Mar 15, 2023
Status verified
Jul 2026
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, substudy C1: 2L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with Paclitaxel. Part C, substudy C2: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane). Part C, substudy C3: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX/mFFX. Part C, substudy C4: 2L BTC patients will receive PT886 in combination with SOC chemotherapy mFOLFOX6.
  • Experimental: Combination Expansion with KEYTRUDA® (pembrolizumab)
    Part D, substudy D3: 2L or 3L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab). Part D, substudy 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 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 ]

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

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
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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