Testing FH-006 injection in patients with advanced solid tumors

A Multicenter, Open Label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of FH-006 for Injection in Patients With Malignant Solid Tumors

This study is testing a new injection called FH-006 to see if it can help people with advanced solid tumors who have run out of other treatment options.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (industry)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06735144 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in patients with advanced malignant solid tumors. It aims to determine the maximum tolerated dose (MTD) and the recommended dose for phase II trials (RP2D), as well as to assess preliminary efficacy. Participants will receive FH-006 and be monitored for their response and any adverse effects. The study focuses on individuals who have experienced disease progression after standard treatments or do not have suitable treatment options.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 75 with recurrent or metastatic solid tumors that have progressed after standard treatment.

Not a fit: Patients with active central nervous system metastasis or those who have undergone recent anti-tumor treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced malignant solid tumors who have limited alternatives.

How similar studies have performed: While this approach is being explored in this trial, similar studies have shown promise in evaluating new treatments for advanced solid tumors.

Eligibility criteria

Inclusion Criteria:

1. Women aged 18 to 75 (inclusive)
2. Subjects with histologically or cytologically confirmed recurrent or metastatic solid tumors who experience disease progression after standard treatment, or who do not have a standard treatment plan or are not suitable for standard treatment.
3. ECOG score is 0 or 1
4. An expected survival of ≥3 months
5. At least one target lesion according to RECIST v1.1 criteria
6. Has a good level of organ function
7. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria:

1. Have other malignancies within the past 5 years
2. Active central nervous system metastasis without surgery or radiotherapy
3. Presence with uncontrollable third space effusion
4. Have undergone other anti-tumor treatment within 4 weeks before the first dose
5. Has severe infection within 4 weeks before the first medication
6. Any active autoimmune disease or a history of autoimmune disease
7. A history of immune deficiency
8. Has serious cardiovascular and cerebrovascular diseases
9. Clinically significant history of lung disease
10. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
11. Having undergone surgery on important organs within 4 weeks prior to the first use of medication
12. Used attenuated live vaccine within 28 days prior to the first use of the investigational drug
13. Presence of other serious physical or mental diseases or laboratory abnormalities

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Xiaoxue Pi

Conditions: Malignant Solid Tumor