Clinical trial NCT06445517: Study Evaluating ISM8207 in Participants With Advanced Solid Tumors and Relapsed/Refractory B-Cell Lymphoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Relapsed/Refractory B-cell Lymphoma
Keywords: Advanced solid tumors
Relapsed/refractory B-cell lymphoma
Lymphoma, B-cell
Lead sponsor: InSilico Medicine Hong Kong Limited
Sponsor class: INDUSTRY
First posted: 2024-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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 SIRPα 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)

Primary outcomes:
measure: Incidence of dose-limiting toxicity (DLT) events
timeFrame: 31 days
measure: Incidence and severity of adverse events (AEs)
timeFrame: Approximately 2 years
measure: Recommended phase 2 dose (RP2D)
timeFrame: 31 days
Secondary outcomes:
measure: objective response rate (ORR)
timeFrame: Approximately 2 years
measure: best objective response (BOR)
timeFrame: Approximately 2 years
measure: duration of response (DoR)
timeFrame: Approximately 2 years
measure: disease control rate (DCR)
timeFrame: Approximately 2 years
measure: progression-free survival (PFS)
timeFrame: Approximately 2 years
measure: 6-month overall survival (OS) rates
timeFrame: Approximately 2 years
measure: 1-year overall survival (OS) rates
timeFrame: Approximately 2 years
measure: maximum observed concentration (Cmax)
timeFrame: Approximately 2 years
measure: time of maximum observed concentration (Tmax)
timeFrame: Approximately 2 years
measure: area under the concentration-time curve (AUC)
timeFrame: Approximately 2 years
measure: terminal half-life (t1/2)
timeFrame: Approximately 2 years
measure: apparent clearance (CL/F)
timeFrame: Approximately 2 years
measure: apparent volume of distribution (Vz/F)
timeFrame: Approximately 2 years
measure: maximum observed concentration at steady state (Css,max)
timeFrame: Approximately 2 years
measure: minimum observed concentration at steady state (Css,min)
timeFrame: Approximately 2 years
measure: average concentration at steady state (Css,av)
timeFrame: Approximately 2 years
measure: time of Css,max (Tss,max)
timeFrame: Approximately 2 years
measure: AUC from time 0 to time dosing interval (AUCss,0-tau)
timeFrame: Approximately 2 years
measure: CLss/Fss
timeFrame: Approximately 2 years
measure: Vz/Fss
timeFrame: Approximately 2 years
measure: accumulation ratio of Cmax (RCmax) after multiple doses
timeFrame: Approximately 2 years
measure: accumulation ratio of AUC (RAUC) after multiple doses
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine-Ruijin Hospital
state: Shanghai
Study officials:
References: