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NCT04586335 · ClinicalTrials.gov registry record · Phase 1
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
A Phase 1 study, sponsored by Haihe Biopharma Co..
- Terminated
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04586335 is a Phase 1 study that was terminated before completion, run by Haihe Biopharma Co.. The registered enrollment target is 24 participants.
The verdict
NCT04586335, a Phase 1 study, was terminated before completion, sponsored by Haihe Biopharma Co..
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of CYH33 in combination with olaprib in patients with DDR gene mutations and/or PIK3CA mutations, in patients who have progressed on prior PARP inhibitor, and in patients with recurrent high grade serous ovarian, fallopian tube, or primary peritoneal cancer who are platinum resistant or refractory. The study will assess if this combination will optimize anti-tumor activity, block tumor growth and overcome the resistance to PARP inhibitor treatment. The study consists 2 parts. In Part 1 dose escalation, the objective is to determine the maximum toleration dose (MTD) of the combination. The final recommended phase 2 dose (RP2D) of CYH33 in combination with olaparib will be based on the totality of an overall assessment of available safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy which could be the MTD or a dose level lower in specific cohorts of patients. In Part 2 dose expansion, the main objective is to evaluate the efficacy at RP2D.
Interventions
- DRUG CYH33
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-09-28 |
| Est. Completion | 2023-02-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04586335
The ClinicalTrials.gov registry entry for NCT04586335 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Haihe Biopharma Co., which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CYH33 is the first listed.
NCT04586335 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04586335 about?
NCT04586335 is a clinical study titled "Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.". The purpose of this study is to assess the safety, tolerability and preliminary efficacy of CYH33 in combination with olaprib in patients with DDR gene mutations and/or PIK3CA mutations, in patients who have progressed on prior PARP inhibitor, and in patients with recurrent high grade serous ovarian...
What is the current status of trial NCT04586335?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-09-28. Estimated completion is 2023-02-15.
What interventions are being tested in trial NCT04586335?
The interventions under investigation include: CYH33 (DRUG).
Who is sponsoring clinical trial NCT04586335?
This trial is sponsored by Haihe Biopharma Co., which has 4 total clinical trials registered on ClinicalTrials.gov.
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