Advanced Solid TumorsPhase 1NCT06445517
Study Evaluating ISM8207 in Participants With Advanced Solid Tumors and Relapsed/Refractory B-Cell Lymphoma
A Phase 1 study testing ISM8207 in people with Advanced Solid Tumors and Relapsed/Refractory B-cell Lymphoma, run by InSilico Medicine Hong Kong Limited at 4 sites in China.
Trial summary
The goal of this clinical trial is to study ISM8207 in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma. The primary objective is to evaluate the safety and tolerability of ISM8207 orally administered in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Relapsed/Refractory B-cell Lymphoma
- What is being tested?
- ISM8207
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesChina
- Study dates
- 25 Apr 2024to 28 Feb 2027
- Phase
- Phase 1
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants with age ≥18 years at the time of signing the informed consent.
- Advanced solid tumors: Histologically confirmed advanced or metastatic solid tumors who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists.
- B-cell lymphoma: Histologically confirmed B-cell lymphoma who had received at least one prior line of standard therapy and were relapsed after or refractory to the standard therapy.
- Have measurable or evaluable lesions in Part 1 and at least one measurable target lesion in Part 2 as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or Lugano 2014.
- ECOG PS (Eastern Cooperative Oncology Group Performance Status)≤1.
- Life expectancy of ≥12 weeks as judged by the investigator.
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- Adequate organ function as determined by medical assessment.
- Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol.
- Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception during the treatment period and for 90 days after the last dose of ISM8207.
Who cannot join
- Prior treated with other QPCTL, CD47 or SIRPα inhibitors.
- Burkitt lymphoma/leukemia, plasma cell myeloma, plasmablastic lymphoma.
- Participation in other therapeutic clinical studies within 28 days or 5 half- lives (whichever is shorter) prior to first dose of study treatment.
- Anti-tumor therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, or other anti-tumor therapy) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment.
- Previous allogeneic stem cell transplantation or autologous stem cell. transplantation within 3 months prior to first receiving study treatment.
- Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding alopecia).
- Received antitumor steroid therapy within 7 days prior to the first study treatment administration.
- A serious illness or medical condition(s)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Juan Xu contact
China4 sites, 4 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
- Recruiting
Shanghai Jiao Tong University School of Medicine-Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
- Recruiting
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality
About this study
Official title: A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ISM8207 Monotherapy in Patients With Advanced Solid Tumors or Relapsed/Refractory B-Lymphoid Malignancies
The goal of this clinical trial is to study ISM8207 in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma. The primary objective is to evaluate the safety and tolerability of ISM8207 orally administered in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma
- Being tested
- ISM8207
- Keywords
- Advanced solid tumors, Relapsed/refractory B-cell lymphoma, Lymphoma, B-cell
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISM8207Drug
Pharmaceutical formulation: Capsules Mode of Administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation: ISM8207 | Experimental | Participants will receive ISM8207 orally once on day 1 during single dose period (3 days) then once daily in repeated 28-day cycles from Cycle 1 onwards. Receives: Drug: ISM8207 |
| Dose Expansion: ISM8207 | Experimental | Participants will receive ISM8207 orally once daily in repeated 28-day cycles. Receives: Drug: ISM8207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT) events
Measured: 31 days
Incidence and severity of adverse events (AEs)
Measured: Approximately 2 years
Recommended phase 2 dose (RP2D)
Measured: 31 days
Secondary outcomes (22)
objective response rate (ORR)
Measured: Approximately 2 years
best objective response (BOR)
Measured: Approximately 2 years
duration of response (DoR)
Measured: Approximately 2 years
disease control rate (DCR)
Measured: Approximately 2 years
progression-free survival (PFS)
Measured: Approximately 2 years
6-month overall survival (OS) rates
Measured: Approximately 2 years
1-year overall survival (OS) rates
Measured: Approximately 2 years
maximum observed concentration (Cmax)
Measured: Approximately 2 years
time of maximum observed concentration (Tmax)
Measured: Approximately 2 years
area under the concentration-time curve (AUC)
Measured: Approximately 2 years
terminal half-life (t1/2)
Measured: Approximately 2 years
apparent clearance (CL/F)
Measured: Approximately 2 years
apparent volume of distribution (Vz/F)
Measured: Approximately 2 years
maximum observed concentration at steady state (Css,max)
Measured: Approximately 2 years
minimum observed concentration at steady state (Css,min)
Measured: Approximately 2 years
average concentration at steady state (Css,av)
Measured: Approximately 2 years
time of Css,max (Tss,max)
Measured: Approximately 2 years
AUC from time 0 to time dosing interval (AUCss,0-tau)
Measured: Approximately 2 years
CLss/Fss
Measured: Approximately 2 years
Vz/Fss
Measured: Approximately 2 years
accumulation ratio of Cmax (RCmax) after multiple doses
Measured: Approximately 2 years
accumulation ratio of AUC (RAUC) after multiple doses
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start25 Apr 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InSilico Medicine Hong Kong Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445517
- Sponsor's protocol ID
- ISM8207_101
- Status last verified
- Jul 2026
- First submitted
- 31 May 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No