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)

StatusRecruiting
PhasePhase 1/2
Started

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Record History

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  1. Enrollment increased: 258 → 350 participants Show 4 more changesShow less
    • Interventions modified
    • Eligibility criteria expanded, about 144 words
    • Collaborators: details revised at 1 of 1 entry
    • Study title expanded, about 6 words
  2. Primary endpoints revised (3)
    • Interventions: Abraxane (Drug), Capecitabine (Drug), FOLFIRINOX (Drug), Fluorouracil (Drug), Gemcitabine (Drug), KEYTRUDA® (pembrolizumab) (Drug)… to Abraxane (Drug), CAPOX (Drug), FOLFIRINOX (Drug), FOLFOX (Drug), Gemcitabine (Drug), KEYTRUDA® (pembrolizumab) (Drug), Paclitaxel (Drug)…
    • Eligibility criteria shortened, about 229 words
    • Secondary endpoints revised (3)
    v18
  3. Site details revised at 1 of 11 sitesv17
  4. Study sites: 6 to 11v16
  5. Enrollment target: 135 to 258
    • Eligibility criteria expanded, about 25 words
    • Study title expanded, about 13 words
    v15
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  1. Primary endpoints revised (3)v14 Show 4 more changesShow less
    • Interventions: Abraxane (Drug), Capecitabine (Drug), FOLFIRINOX (Drug), Fluorouracil (Drug), Gemcitabine (Drug), KEYTRUDA® (pembrolizumab) (Drug)… to Abraxane (Drug), Capecitabine (Drug), FOLFIRINOX (Drug), Fluorouracil (Drug), Gemcitabine (Drug), KEYTRUDA® (pembrolizumab) (Drug)…
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (3)
    • Study title expanded, about 1 word
  2. Primary endpoints: 4 to 3
    • Secondary endpoints revised (3)
    • Site contacts updated at 6 of 6 sites
    v13
  3. Primary completion date: Dec 2025 to Dec 2027v12 Show 5 more changesShow less
    • Enrollment target: 114 to 135
    • Study sites: 5 to 6
    • Study completion date: Apr 2026 to Apr 2028
    • Interventions: Abraxane (Drug), Capecitabine (Drug), Fluorouracil (Drug), Gemcitabine (Drug), KEYTRUDA® (pembrolizumab) (Drug), Leucovorin (Drug)… to Abraxane (Drug), Capecitabine (Drug), FOLFIRINOX (Drug), Fluorouracil (Drug), Gemcitabine (Drug), KEYTRUDA® (pembrolizumab) (Drug)…
    • Eligibility criteria shortened, about 1,516 words
  4. Site contacts updated at 1 of 5 sitesv11
  5. Study sites: 4 to 5v10
  6. Re-verified, no change to tracked fieldsv9
  7. Enrollment target: 72 to 114v8 Show 4 more changesShow less
    • Interventions: Abraxane (Drug), Gemcitabine (Drug), PT886 (Drug), Paclitaxel (Drug) to Abraxane (Drug), Capecitabine (Drug), Fluorouracil (Drug), Gemcitabine (Drug), KEYTRUDA® (pembrolizumab) (Drug), Leucovorin (Drug)…
    • Eligibility criteria expanded, about 337 words
    • Study arms: 3 to 4
    • Collaborators expanded, about 5 words
  8. Site contacts updated at 3 of 4 sitesv7
  9. Phase: Phase 1 to Phase 1/2v6 Show 11 more changesShow less
    • Primary completion date: Nov 2023 to Dec 2025
    • Start date: Nov 17, 2022 to Mar 15, 2023
    • Primary endpoints: 3 to 4
    • Enrollment target: 58 to 72
    • Study sites: 1 to 4
    • Study completion date: Apr 2024 to Apr 2026
    • Interventions: PT886 (Drug) to Abraxane (Drug), Gemcitabine (Drug), PT886 (Drug), Paclitaxel (Drug)
    • Eligibility criteria expanded, about 476 words
    • Secondary endpoints: 1 to 3
    • Study arms: 2 to 3
    • Study title expanded, about 3 words
  10. Site contact updatedv5
  11. Re-verified, no change to tracked fieldsv4
  12. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Aug 2023 to Nov 2023
    • Study completion date: Jan 2024 to Apr 2024
    • Start date changed from estimate of Aug 2022 to Nov 17, 2022
  13. Secondary endpoints expanded, about 12 wordsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05482893
Lead Sponsor Phanes Therapeutics
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Gastric or Gastroesophageal Junction Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer (BTC), Colorectal Cancer
Related terms Biliary Tract Neoplasms, Colorectal Neoplasms
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov