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Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors

ConditionsAdvanced Solid TumorMetastatic Solid TumorAdvanced and/or Metastatic Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInSilico Medicine Hong Kong Limited

About this trial

This is a first-in-human Phase 1a/b, open-label, multicenter, dose escalation, optimization and expansion study of ISM5939 to evaluate the safety, tolerability, PK, PD, and preliminary antitumor activity of ISM5939 in patients with advanced or metastatic solid tumors.

The study will be conducted in 3 parts sequentially: Part 1 dose escalation ISM5939 monotherapy, Part 2 dose optimization to determine RP2D of ISM5939 monotherapy, and Part 3 dose expansion in 3 cohorts after initial safety run-in of ISM5939 combination therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥18 years.

Patients with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor that is either locally advanced and not amenable to curative therapy or stage 4 disease.

Patients must have tumor relapse/recurrence and be refractory to available SOC treatment, be intolerant to or ineligible for available SOC treatment, or have no SOC treatment available.

Patients enrolled in Part 3 (combination cohorts) must be acceptable and eligible for treatment with cisplatin, docetaxel, or pembrolizumab.

Disqualifiers

Patient has had prior systemic anti-cancer therapy within 3 weeks or at least 5 half-lives (whichever is shorter, but no less than 2 weeks) prior to Day 1.

Prior radiation therapy at the target lesion, unless there is evidence of disease progression and the prior radiation therapy is to have been completed at least 7 days before study drug.

Treatment with any investigational agent administered within 30 days or 5 half-lives, whichever is shorter, before the first dose of ISM5939.

Prior therapy with an ENPP1 inhibitor.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ISM5939

    Drug

    ISM5939 tablets will be administered orally once daily (QD).

  • Cisplatin

    Drug

    Cisplatin will be administered intravenously in combination with ISM5939 on day 1 during each cycle.

  • Docetaxel

    Drug

    Docetaxel will be administered intravenously in combination with ISM5939 on day 1 during each cycle.

  • Pembrolizumab

    Drug

    Pembrolizumab will be administered intravenously in combination with ISM5939 on day 1 during each cycle.

Treatment groups

159 Participants
are divided into 3 treatment groups
Group A: Part 1 Dose escalationExperimental treatment 1 intervention
Group B: Part 2 Dose optimizationExperimental treatment 1 intervention
Group C: Part 3 Dose expansionExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Dose-limiting toxicities (DLTs) occurrence

DLT is defined as any of the adverse event which meets DLT criteria if assessed at least possibly related to study treatment and not clearly related to progressive disease or other extraneous cause and occurring during the DLT period.

Time frame
Day 1 up to Day 28 for Part 1 and Day 1 up to Day 21 for Part 3 safety run-in dose escalation period
2

Adverse events (AEs)

Incidence and severity of AEs will be evaluated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 \[NCI CTCAE v5.0\]).

Time frame
Approximately 36 months
3

Recommended Phase 2 doses (RP2Ds)

The maximum tolerated dose (MTD) or RP2Ds in patients with advanced or metastatic solid tumors will be determined based on the available data of safety and tolerability, PK, PD and preliminary activity from all dosed patients.

Time frame
Approximately 36 months

Secondary outcomes

1

Maximum concentration (Cmax)

Blood samples for Pharmacokinetics (PK) analysis will be assessed after dose of ISM5939.

Time frame
Approximately 36 months
2

Area under the concentration-time curve (AUC)

Blood samples for Pharmacokinetics (PK) analysis will be assessed after dose of ISM5939.

Time frame
Approximately 36 months
3

Terminal half-life (t1/2)

Blood samples for Pharmacokinetics (PK) analysis will be assessed after dose of ISM5939.

Time frame
Approximately 36 months
4

Objective response rate (ORR)

ORR is defined as the percentage of participants with Complete Response or Partial Response.

Time frame
Approximately 36 months

Other outcomes

Locations

This trial has no locations.

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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