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A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 170 to confirmed 72
    • Site details revised at 10 of 10 sites
    v11
  2. Re-verified, no change to tracked fieldsv10
  3. Site details revised at 2 of 10 sitesv9
  4. Primary and study completion dates: Dec 2024 to Dec 2026v8 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 10 to 9
    • Study description shortened, about 36 words
  5. Site details revised at 1 of 10 sitesv7
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  1. Enrollment target: 90 to 170v6 Show 8 more changesShow less
    • Primary and study completion dates: Jan 2024 to Dec 2024
    • Primary endpoints revised (2)
    • Interventions: HFB200301 (Drug), HFB200301 (Drug) to HFB200301 (Drug), Tislelizumab (Drug)
    • Eligibility criteria expanded, about 72 words
    • Secondary endpoints revised (10)
    • Study description expanded, about 8 words
    • Study title expanded, about 9 words
    • Study arms: 2 to 4
  2. Study sites: 5 to 10v5
  3. Study sites: 3 to 5v4
  4. Start date changed from estimate of Mar 2022 to Mar 10, 2022v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2022 to Mar 2022
    • Site details revised at 3 of 3 sites
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
HiFiBiO Therapeutics
2 trials monitored
See all monitored trials
Lung Cancer
4,790 trials monitored
See 263 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,078 trials monitored
See 172 trials at risk
Head & Neck Cancer
2,605 trials monitored
See 150 trials at risk
and 6 more diseases
The purpose of this study is to test the safety and tolerability of HFB200301 as a single agent and in combination with tislelizumab in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses of HFB200301 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200301 as a single agent or combination therapy is determined. During the expansion part, participants will take the dose of HFB200301 as a monotherapy or in combination with tislelizumab that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.
Trial Details
NCT Number NCT05238883
Lead Sponsor HiFiBiO Therapeutics
Conditions
(from sponsor)		 Gastric Cancer, Renal Cell Carcinoma, Melanoma, Sarcoma, Testicular Germ Cell Tumor, Cervical Cancer, Mesothelioma, Non Small Cell Lung Cancer +1 more
Related terms Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Melanoma, Mesothelioma, Sarcoma, Squamous Cell Carcinoma of Head and Neck, Stomach Neoplasms, Testicular Germ Cell Tumor, Uterine Cervical Neoplasms
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov