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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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.

Yichen Liu contact

021-50831718

Insilico-Clinicaltrial@insilico.ai

Juan Xu contact

Insilico-Clinicaltrial@insilico.ai

China4 sites, 4 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

    Recruiting

Other trials in China

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 groups in NCT06445517
Study groupRoleWhat they receive
Dose Escalation: ISM8207ExperimentalParticipants 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: ISM8207ExperimentalParticipants 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.

  1. Incidence of dose-limiting toxicity (DLT) events

    Measured: 31 days

  2. Incidence and severity of adverse events (AEs)

    Measured: Approximately 2 years

  3. Recommended phase 2 dose (RP2D)

    Measured: 31 days

Secondary outcomes (22)

  1. objective response rate (ORR)

    Measured: Approximately 2 years

  2. best objective response (BOR)

    Measured: Approximately 2 years

  3. duration of response (DoR)

    Measured: Approximately 2 years

  4. disease control rate (DCR)

    Measured: Approximately 2 years

  5. progression-free survival (PFS)

    Measured: Approximately 2 years

  6. 6-month overall survival (OS) rates

    Measured: Approximately 2 years

  7. 1-year overall survival (OS) rates

    Measured: Approximately 2 years

  8. maximum observed concentration (Cmax)

    Measured: Approximately 2 years

  9. time of maximum observed concentration (Tmax)

    Measured: Approximately 2 years

  10. area under the concentration-time curve (AUC)

    Measured: Approximately 2 years

  11. terminal half-life (t1/2)

    Measured: Approximately 2 years

  12. apparent clearance (CL/F)

    Measured: Approximately 2 years

  13. apparent volume of distribution (Vz/F)

    Measured: Approximately 2 years

  14. maximum observed concentration at steady state (Css,max)

    Measured: Approximately 2 years

  15. minimum observed concentration at steady state (Css,min)

    Measured: Approximately 2 years

  16. average concentration at steady state (Css,av)

    Measured: Approximately 2 years

  17. time of Css,max (Tss,max)

    Measured: Approximately 2 years

  18. AUC from time 0 to time dosing interval (AUCss,0-tau)

    Measured: Approximately 2 years

  19. CLss/Fss

    Measured: Approximately 2 years

  20. Vz/Fss

    Measured: Approximately 2 years

  21. accumulation ratio of Cmax (RCmax) after multiple doses

    Measured: Approximately 2 years

  22. 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.

  1. First posted6 Jun 2024
  2. Study start25 Apr 2024
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yichen Liu (021-50831718, Insilico-Clinicaltrial@insilico.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicity (DLT) events (time frame: 31 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06445517.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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