Malignant Solid TumorPhase 1/2NCT06735144
Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors
A Phase 1/2 study testing FH-006 in people with Malignant Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Solid Tumor
- What is being tested?
- FH-006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2024to Dec 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang
About this study
Official title: 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
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
- Being tested
- FH-006
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FH-006Drug
Intravenous injection once every two weeks (Q2W), with a treatment period of 28 days
FH-006Drug
administered once every 3 weeks (Q3W), with a treatment period of 21 days
| Study group | Role | What they receive |
|---|---|---|
| Queue A | Experimental | Not described Receives: Drug: FH-006 |
| Queue B | Experimental | Not described Receives: Drug: FH-006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT: 21or28 days after the first administration of each subject
Measured: 21or28 days after the first administration of each subject
AE: from Day1 to 30 days after last dose
Measured: from Day1 to 30 days after last dose
Incidence and severity of serious adverse events (SAE): from Day1 to 30 days after last dose
Measured: 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
Measured: 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
Measured: Obtain two treatment evaluation data for the last subject during the dose expansion phase
Secondary outcomes (1)
Immunogenic indicators: anti-FH-006 antibody (ADA)
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start23 Dec 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735144
- Sponsor's protocol ID
- FH-006-101
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided