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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations

ConditionsAdvance Solid TumorsColon and Rectal CancerNon - Small Cell Lung Cancer NSCLCPancreatic Adenocarcinoma Advanced or MetastaticOvarian CancerEndometrial CancerBiliary Cancers
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen Ionova Life Sciences Co., Ltd.

About this trial

This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-8989 in patients with advanced solid tumors harboring KRAS G12D mutations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent obtained.

Adult patients aged ≥ 18 years.

Patients with histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumors harboring the KRAS G12D mutations.

Agree to provide available archived FFPE tumor tissue specimens or voluntarily accept pre-treatment tumor biopsy.

Disqualifiers

Have protocol-defined toxicities within 28 days before the start of study treatment.

Have a second primary malignancy.

Patients with known hypersensitivity to the study drug or any of its components.

Prior history of receiving targeted therapy with specific KRAS G12D inhibitors/degraders or pan-RAS inhibitors/degraders for KRAS G12D mutation.

Trial design

Design model

Sequential

Treatments tested in this trial

  • INV-8989

    Drug

    INV-8989 is admistered once weekly

Treatment groups

178 Participants
are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.

Group A: Phase 1 INV-8989 Dose escalation Dose level 1Experimental treatment 1 intervention
Group B: Phase 1 INV-8989 Dose escalation Dose level 2Experimental treatment 1 intervention
Group C: Phase 1 INV-8989 Dose escalation Dose level 3Experimental treatment 1 intervention
Group D: Phase 1 INV-8989 Dose escalation Dose level 4Experimental treatment 1 intervention
Group E: Phase 1 INV-8989 Dose escalation Dose level 5Experimental treatment 1 intervention
Group F: Phase 1 INV-8989 Dose escalation Dose level 6Experimental treatment 1 intervention
Group G: Phase 1 INV-8989 Dose escalation Dose level 7Experimental treatment 1 intervention
Group H: Phase 1 INV-8989 Dose escalation Dose level 8Experimental treatment 1 intervention
Group I: Phase 2a INV-8989 Dose level 1Experimental treatment 1 intervention
Group J: Phase 2a INV-8989 Dose level 2Experimental treatment 1 intervention
Group K: Phase 2b INV-8989 cohort AExperimental treatment 1 intervention
Group L: Phase 2b INV-8989 cohort BExperimental treatment 1 intervention
Group M: Phase 2b INV-8989 cohort CExperimental treatment 1 intervention
Group N: Phase 2b INV-8989 cohort DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1: Number of participants with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

The number and percentage of participants with at least one TEAE will be summarized by severity grade and relationship to study drug.

Time frame
12 months
2

Phase 1: Maximum tolerated dose (MTD)

The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT.

Time frame
Within first 21 days of treatment
3

Phase 1: Recommended dose range (RDR) and/or Recommended Phase Ⅱ dose (RP2D)

The RDR and/or RP2D will be determined based on the PK and PD data, the preliminary clinical activity of INV-8989, as well as the incidence rate and nature of the toxicities observed in subsequent cycles beyond Cycle 1.

Time frame
12 months
4

Phase 2: Evaluate overall response rate (ORR)

To evaluate ORR per RECIST v1.1

Time frame
12 months

Secondary outcomes

1

Phase 1: Determine the pharmacokinetics (PK) using AUC of INV-8989

To determine the (PK) using AUC of INV-8989 after a single dose and at steady state after multiple doses

Time frame
12 months
2

Phase 1: Determine the PK using Cmax of INV-8989

Determine the PK using Cmax of INV-8989 after a single dose and at steady state after multiple doses

Time frame
12 months
3

Phase 1: Evaluate overall response rate (ORR)

To evaluate ORR per RECIST v1.1

Time frame
12 months
4

Phase 1: Evaluate progression free survival (PFS)

To evaluate PFS per RECIST v1.1

Time frame
12 months

Other outcomes

Sponsors and contacts

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

Shenzhen Ionova Life Sciences Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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