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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor

ConditionsBreast Cancer (Locally Advanced or Metastatic)Advanced Solid CancersMetastatic (Stage IV) Breast CancerOvarian CancerEndometrial Cancer
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-6452 in adult patients with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) advanced/metastatic breast cancer or locally advanced/metastatic solid tumor.

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 unresectable locally advanced or metastatic solid tumors, who have disease progression following standard-of-care therapy, are intolerant to standard treatment, or have no available standard treatment options (e.g., HR+/HER2- breast cancer, Cyclin E1-overexpressing solid tumors and other solid tumors).

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

Disqualifiers

Have a second primary malignancy.

Patients with primary CNS tumors or CNS metastases with prior local treatment failure.

Have received any anti-tumor therapy or participated in other therapeutic clinical trial within 28 days prior to the first dose of study drug.

Has undergone major surgery within 28 days prior to the first dose of study drug.

Trial design

Design model

Sequential

Treatments tested in this trial

  • INV-6452

    Drug

    once daily orally

Treatment groups

201 Participants
are divided into 2 treatment groups
Group A: Phase 1 INV-6452 Dose escalationExperimental treatment 1 intervention
Group B: Phase 2 INV-6452 Dose expansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 28 days of treatment
2

Phase 1: Recommended dose range (RDR)

The RDR will be determined based on the PK and PD data, the preliminary clinical activity of INV-6452, as well as the incidence rate and nature of the toxicities observed in subsequent cycles beyond Cycle 1.

Time frame
12 months
3

Phase 2: Evaluate overall response rate (ORR)

The RDR will be determined based on the PK and PD data, the preliminary clinical activity of INV-6452, as well as the incidence rate and nature of the toxicities observed in subsequent cycles beyond Cycle 1.

Time frame
12 months

Secondary outcomes

1

Phase 1: Determine the pharmacokinetics (PK) using AUC of INV-6452

To determine the PK using AUC of INV-6452 after a single dose and at steady state after multiple doses for Phase 1

Time frame
12 months for Phase 1
2

Phase 2: Determine the PK using AUC of INV-6452

To determine the PK using AUC of INV-6452 after a single dose and at steady state after multiple doses for Phase 2

Time frame
12 months for Phase 2

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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