Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: CYH33 for tablet

• Registration Number: NCT03544905
• Lead Sponsor: Haihe Biopharma Co., Ltd.

Brief Summary

This study is a Multi-center, Open-label, single arm, Dose Escalation and Dose Extension Phase 1 Study to Evaluate the Safety , Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Advanced Solid Tumors Patients.

Detailed Description

This study includes Phase Ia and Phase Ib.

In the dose climbing part of phase Ia, the safety, tolerance and pharmacokinetics characteristics of CYH33 in patients with advanced solid tumors who failed to receive standard treatment, did not tolerate or did not have standard treatment at present will be observed to determine MTD; Before determining MTD, select safe and highly reliable and effective dose levels for simultaneous expansion. Phase Ia dose expansion includes patients with advanced solid tumors who have failed to undergo standard treatment, who are intolerant of PIK3CA gene mutation, or who do not have standard treatment at present, to further evaluate safety, tolerance and initial efficacy.

In Phase Ib, the safety and preliminary efficacy of CYH33 on patients with advanced breast cancer, ovarian cancer, endometrial cancer, cervical cancer, head and neck squamous cell carcinoma, esophageal and gastroesophageal junction squamous cell carcinoma, ovarian clear cell carcinoma and other solid tumors with PIK3CA gene mutation who have failed, are intolerant or do not have standard treatment at present will be evaluated.

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-06-04
• Study Start: 2018-07-05
• Primary Completion: 2024-12-04
• Study Completion: 2024-12-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• main inclusion:

  1. Evidence of a personally signed informed consent document;
  2. Male and/or female subjects above the ages of 18 years;
  3. Locally advanced or metastatic solid tumor patients who have failed or relapsed on current standard of care for Phase 1a;
  4. Subject may provide Tumor tissue section(at least 8 pieces) if they agree;
  5. ECOG performance score 0-1;
  6. Life expectancy ≥ 12 weeks;
  7. At least 1 measurable target lesion on the baseline scan as per RECIST 1.1

Exclusion Criteria

• main criteria:

  1. prior received anti-tumor treatment, including anticancer drugs for the treatment within 28 days of first dose of study treatment;
  2. Prior or concomitant other malignant tumor;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalation study of CYH33	CYH33 for tablet	To determine the maximum tolerated dose (MTD) of CYH33

Primary Outcome Measures

Name	Time	Method
MTD(Max tolerance does)	35 days	To evaluate the MTD in patients with advanced solid tumor

Trial Locations

Locations (30)

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

Lu'an People's Hospital; 🇨🇳 Lu'an, Anhui, China

Lu'an Hospital of Traditional Chinese Medicine; 🇨🇳 Lu'an, Anhui, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Chongqing Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

Xiang'an Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

Dongguan People's Hospital; 🇨🇳 Dongguan, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 GuangZhou, Guangdong, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

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