A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors

ConditionAdvanced Solid Tumor

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-89

SponsorEikon Therapeutics

About this trial

This study investigates the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EIK1003 in participants with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Breast cancer; must have received at least one prior chemotherapy in neoadjuvant/adjuvant/metastatic setting, must have received hormonal therapy if HR+,

HGSOC or high grade endometrioid EOC, fallopian tube or primary peritoneal cancer; must have received at least one prior platinum-based chemotherapy for advanced disease

mCRPC with ongoing ADT, must have received NHA and up to 1 prior line of taxane chemotherapy

Age ≥ 18 years at the time of informed consent

Disqualifiers

Any investigational or approved anti-cancer therapies administered within 28 days/ before the first dose of IMP1734

Have received prior PARP1 selective inhibitors

Mean resting QTcF > 470 ms or QTcF < 340 ms

Active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.

Trial design

Design model

Sequential

Treatments tested in this trial

IMP1734
Drug
PARP1 selective inhibitor

Treatment groups

156 Participants

are divided into 1 treatment group

Group A: Cohort 1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Number of subjects with adverse events, treatment emergent adverse events or serious adverse events

Number of subjects reporting adverse events or serious adverse events which include any abnormal clinical events, laboratory assessments outside of normal clinical range, abnormal vital signs observed, and any abnormal ECG parameters

Time frame

Consent to 30 + 7 days post last dose of IMP1734

Maxim Tolerated Dose or Recommended Dose for Expansion

Number of patients that experience a DLT or any toxicity which occurs from the time of the first dose of study drug until the end of cycle 1, which is deemed unrelated to the disease.

Time frame

DLT period is from the first dose of the study drug until the last day of the first cycle