Health TrialsbyHealthPanel

Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors

ConditionLocally Advanced/Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInSilico Medicine Hong Kong Limited

About this trial

The study has consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2). The primary objectives of this study are to evaluate the safety and tolerability of ISM3412 in participants with locally advanced/metastatic solid tumors, and to determine the RP2D of ISM3412.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Histologically confirmed unresectable locally advanced or metastatic solid tumors with confirmed homozygous MTAP deletion, who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists.

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.

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

Disqualifiers

Prior treated with other MAT2A inhibitors and/or PRMT inhibitors.

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, hormonal therapy, targeted therapy, biologic therapy, or other anti-tumor therapy, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogues, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment.

Toxicities of prior therapy have not resolved to Grade ≤1 or to baseline (as evaluated by NCI CTCAE version 5.0)

Trial design

Design model

Sequential

Treatments tested in this trial

  • ISM3412

    Drug

    ISM3412 will be administered orally once daily.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Part 1 Dose EscalationExperimental treatment 1 intervention
Group B: Part 2 Dose Selection OptimizationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicity (DLT) events

To evaluate the safety and tolerability of ISM3412.

Time frame
31 days
2

Incidence and severity of adverse events (AEs)

To evaluate the safety and tolerability of ISM3412.

Time frame
Approximately 30 months
3

Recommended phase 2 dose (RP2D)

To determine the RP2D of ISM3412.

Time frame
Approximately 30 months

Secondary outcomes

1

Maximum observed concentration (Cmax)

To assess PK of ISM3412 in plasma following a single and multiple doses of ISM3412

Time frame
Approximately 30 months
2

Time of maximum observed concentration (Tmax)

To assess PK of ISM3412 in plasma following a single and multiple doses of ISM3412

Time frame
Approximately 30 months
3

Area under the concentration-time curve (AUC)

To assess PK of ISM3412 in plasma following a single and multiple doses of ISM3412

Time frame
Approximately 30 months
4

Terminal half-life (t1/2)

To assess PK of ISM3412 in plasma following a single and multiple doses of ISM3412

Time frame
Approximately 30 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

InSilico Medicine Hong Kong Limited

Lead sponsor

Source ClinicalTrials.gov
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