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A Study of PHST001 in Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints removed 11 → 8 primary endpoints
See other at-risk trials from Pheast Therapeutics

Record History

  1. Primary endpoint(s) modified Enrollment increased: 272 → 426 participants · Interventions modified · Trial arms changed: 2 → 10 · 3 more Show 6 more changesShow less
    • Enrollment increased: 272 → 426 participants
    • Interventions modified
    • Trial arms changed: 2 → 10
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints revised (12)
    • Site details revised at 19 of 20 sites
  2. Study sites revised (20)v8 See this version in full on ClinicalTrials.gov ↗
  3. Site details revised at 3 of 20 sitesv7
  4. Secondary endpoints: details revised at 2 of 12 entriesv6
  5. Enrollment target: 155 to 272 Primary endpoints: 2 to 11 · Study sites: 10 to 20 · Interventions: PHST001 (Drug) to Chemotherapy per Standard of Care (Drug), PHST001 (Biological) · 3 morev5 Show 6 more changesShow less
    • Primary endpoints: 2 to 11
    • Study sites: 10 to 20
    • Interventions: PHST001 (Drug) to Chemotherapy per Standard of Care (Drug), PHST001 (Biological)
    • Eligibility criteria shortened, about 68 words
    • Secondary endpoints: 3 to 12
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

Show 3 earlier versionsHide 3 earlier versions
  1. Site details revised at 7 of 10 sitesv4
  2. Study sites: 1 to 10v3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Mar 2025 to Mar 31, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2025 to Mar 31, 2025
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
Pheast Therapeutics
1 trial monitored
See 1 trial at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
Ovarian Cancer
1,245 trials monitored
See 80 trials at risk
Sarcoma
951 trials monitored
See 56 trials at risk
and 2 more diseases
This is a multi-center, first-in-human (FIH), open-label, Phase 1a/1b dose escalation and dose expansion study to assess the safety, PK, pharmacodynamics, and antitumor activity of PHST001 monotherapy (Phase 1a) or in combination with anticancer therapies (Phase 1b) in adult participants with advanced relapsed and/or refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). Phase 1b will include the following cohorts 1) tumor-specific cohorts for participants with advanced relapsed and/or refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma, 2) a randomized cohort for participants with ovarian cancer who will receive PHST001 in combination with mirvetuximab soravtansine, 3) a cohort for participants with advanced/metastatic breast cancer who will receive PHST001 in combination with trastuzumab deruxtecan and 4) a cohort of patients who consent to additional biomarker studies. The study's primary objectives are to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 as monotherapy and in combination with anticancer therapies, as well as to assess the anti-tumor activity of PHST001 in combination with anticancer therapies in Phase 1b.
Trial Details
NCT Number NCT06840886
Lead Sponsor Pheast Therapeutics
Conditions Advanced Solid Tumors, Ovarian Cancer, Endometrial Cancer, Cholangiocarcinoma, CNS Tumor, Breast Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma +1 more
Enrollment 426 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov