Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors

NCT06735144 | Recruiting Phase 1

• 1 other identifier: FH-006-101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), recommended dose for phase II clinical trials (RP2D), and preliminary efficacy.

Conditions

Malignant Solid Tumor

Outcome Measures

Primary Outcomes (5)

• DLT: 21or28 days after the first administration of each subject

  21or28 days after the first administration of each subject

• AE: from Day1 to 30 days after last dose

  from Day1 to 30 days after last dose

• Incidence and severity of serious adverse events (SAE): from Day1 to 30 days after last dose

  from Day1 to 30 days after last dose

• MTD or MAD： 21 or 28 days after the first dose of medication for each subject on dose escalation stage

  21 or 28 days after the first dose of medication for each subject on dose escalation stage

• RP2D：Obtain two treatment evaluation data for the last subject during the dose expansion phase

  Obtain two treatment evaluation data for the last subject during the dose expansion phase

Secondary Outcomes (1)

• Immunogenic indicators: anti-FH-006 antibody (ADA)

  through study completion, an average of 2 years

Study Arms (2)

Queue A

EXPERIMENTAL

Drug: FH-006

Queue B

EXPERIMENTAL

Drug: FH-006

Interventions

FH-006 DRUG

Intravenous injection once every two weeks (Q2W), with a treatment period of 28 days

Queue A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 to 75 (inclusive)
• 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.
• ECOG score is 0 or 1
• An expected survival of ≥3 months
• At least one target lesion according to RECIST v1.1 criteria
• Has a good level of organ function
• Patients voluntarily joined the study and signed informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Central Study Contacts

Xiaoxue Pi

CONTACT

0518-82342973; Xiaoxue.pi@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 16, 2024
• Study Start: December 23, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2024-12

Locations

CN (1)