HBT-708 for people with advanced solid tumors
Official title: A Phase I Study to Evaluate the Safety, Tolerability, and Initial Efficacy of HBT-708 Monotherapy for Patients With Advanced Solid Tumors
Run by Shenyang Sunshine Pharmaceutical Co., LTD. · NCT06993870 · Data updated 2026-11-12
This trial will test whether HBT-708 given intravenously every three weeks is safe, tolerable, and might help people with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Shenyang Sunshine Pharmaceutical Co., LTD. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | June 16, 2025 |
| Main results expected | March 1, 2026 |
| Study ends | June 28, 2027 |
| Registry record updated | July 11, 2025 |
| Trial ID | NCT06993870 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with histologically or cytologically confirmed advanced or measurable solid tumors, ECOG 0–1, life expectancy ≥3 months, and adequate organ and marrow function are the intended participants.
✕Probably not a fit
Patients with uncontrolled or symptomatic central nervous system metastases, inadequate organ or bone marrow function, pregnancy or breastfeeding, or known hypersensitivity to HBT-708 are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1, first-in-human trial gives HBT-708 as a single-agent intravenous infusion every three weeks using an accelerated titration combined 3+3 dose-escalation design followed by dose-expansion cohorts. The primary focus is on safety and tolerability, with preliminary measures of anti-tumor activity recorded at prespecified dose levels. Eligible adults must have histologically or cytologically confirmed advanced or measurable solid tumors, an ECOG performance status of 0–1, and adequate organ function. The trial is conducted at Shanghai General Hospital with planned cohorts to define a recommended dose for further study.
Why it matters
Potential benefit: If successful, HBT-708 could provide a new treatment option with manageable side effects for some patients with advanced solid tumors.
How similar studies have gone: The accelerated titration combined 3+3 dose-escalation design is a standard approach in early oncology trials and has supported development of other cancer drugs, but HBT-708 itself is novel and unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female subjects, age 18 years or older. 2. Histologically and/or cytologically documented advanced or measurable solid tumors. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Life expectancey \> = 3 months. 5. Willingness to provide written informed consent for the study. Exclusion Criteria: 1. Known uncontrolled or symptomatic central nervous system metastatic disease. 2. Subjects must have recovered (≤ Grade 1 or pretherapy baseline) from AEs due to previously administered therapies. (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0). 3. Inadequate organ or bone marrow function. 4. Pregnant or breast-feeding woman. 5. Known allergies, hypersensitivity, or intolerance to HBT-708 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Where it's running
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Shanghai General Hospital
Shanghai, Shanghai Municipality, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.