Study of ISM5939 in Patients With Advanced 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
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
Treatments tested in this trial
- ISM5939
- Cisplatin
- Docetaxel
- Pembrolizumab
Treatment groups
159 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov