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A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 2025 to Dec 2026v14
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 11 of 11 sites
    v13
  3. Site details revised at 1 of 11 sitesv12
  4. Re-verified, no change to tracked fieldsv11
  5. Site details revised at 2 of 11 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Re-verified, no change to tracked fieldsv9
  2. Study sites: 8 to 11v8
  3. Study sites: 6 to 8v7
  4. Study sites: 3 to 6v6
  5. Study sites: 2 to 3v5
  6. Study sites: 1 to 2v4
  7. Start date changed from estimate of Apr 2023 to May 9, 2023v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Mar 2023 to Apr 2023
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
Colorectal Cancer
3,394 trials monitored
See 159 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,078 trials monitored
See 172 trials at risk
and 3 more diseases
The purpose of this study is to test the safety and tolerability of HFB200603 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 HFB200603 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200603 as a single agent or combination therapy is determined. During the expansion part, participants will take the doses of HFB200603 as a monotherapy (optional arm) or in combination with tislelizumab that were 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 NCT05789069
Lead Sponsor HiFiBiO Therapeutics
Conditions
(from sponsor)		 Renal Cell Carcinoma, Melanoma, Non Small Cell Lung Cancer, Gastric Cancer, Colorectal Cancer
Related terms Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Colorectal Neoplasms, Melanoma, Stomach Neoplasms
Enrollment 83 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov