Study Evaluating ISM8207 in Participants With Advanced Solid Tumors and Relapsed/Refractory B-Cell Lymphoma

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06445517
• Other study ID #: ISM8207_101
• Status: Recruiting
• Phase: Phase 1
• Start date: April 25, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: May 2024
• Source: InSilico Medicine Hong Kong Limited
• Contact: Yichen Liu
• Phone: 021-50831718
• Email: Insilico-Clinicaltrial[@]insilico.ai
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2027
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female participants with age =18 years at the time of signing the informed consent.

2. 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.

3. 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.

4. ECOG PS (Eastern Cooperative Oncology Group Performance Status)=1.

5. Life expectancy of =12 weeks as judged by the investigator.

6. Adequate organ function as determined by medical assessment.

7. Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol.

8. 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.

Exclusion Criteria:

1. Prior treated with other QPCTL, CD47 or SIRPa inhibitors.

2. Burkitt lymphoma/leukemia, plasma cell myeloma, plasmablastic lymphoma.

3. Participation in other therapeutic clinical studies within 28 days or 5 half- lives (whichever is shorter) prior to first dose of study treatment.

4. 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.

5. Previous allogeneic stem cell transplantation or autologous stem cell. transplantation within 3 months prior to first receiving study treatment.

6. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding alopecia).

7. Received antitumor steroid therapy within 7 days prior to the first study treatment administration.

8. A serious illness or medical condition(s)

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Lymphoma
• Lymphoma, B-Cell
• Relapsed/Refractory B-cell Lymphoma

Intervention

Drug:
• ISM8207
Pharmaceutical formulation: Capsules Mode of Administration: Oral

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Shanghai Jiao Tong University School of Medicine-Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
InSilico Medicine Hong Kong Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicity (DLT) events		31 days
Primary	Incidence and severity of adverse events (AEs)		Approximately 2 years
Primary	Recommended phase 2 dose (RP2D)		31 days
Secondary	objective response rate (ORR)		Approximately 2 years
Secondary	best objective response (BOR)		Approximately 2 years
Secondary	duration of response (DoR)		Approximately 2 years
Secondary	disease control rate (DCR)		Approximately 2 years
Secondary	progression-free survival (PFS)		Approximately 2 years
Secondary	6-month overall survival (OS) rates		Approximately 2 years
Secondary	1-year overall survival (OS) rates		Approximately 2 years
Secondary	maximum observed concentration (Cmax)		Approximately 2 years
Secondary	time of maximum observed concentration (Tmax)		Approximately 2 years
Secondary	area under the concentration-time curve (AUC)		Approximately 2 years
Secondary	terminal half-life (t1/2)		Approximately 2 years
Secondary	apparent clearance (CL/F)		Approximately 2 years
Secondary	apparent volume of distribution (Vz/F)		Approximately 2 years
Secondary	maximum observed concentration at steady state (Css,max)		Approximately 2 years
Secondary	minimum observed concentration at steady state (Css,min)		Approximately 2 years
Secondary	average concentration at steady state (Css,av)		Approximately 2 years
Secondary	time of Css,max (Tss,max)		Approximately 2 years
Secondary	AUC from time 0 to time dosing interval (AUCss,0-tau)		Approximately 2 years
Secondary	CLss/Fss		Approximately 2 years
Secondary	Vz/Fss		Approximately 2 years
Secondary	accumulation ratio of Cmax (RCmax) after multiple doses		Approximately 2 years
Secondary	accumulation ratio of AUC (RAUC) after multiple doses		Approximately 2 years