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

NCT07612891 | Recruiting Phase 1

• 1 other identifier: INV-6452-101
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer (Locally Advanced or Metastatic); Advanced Solid Cancers; Metastatic (Stage IV) Breast Cancer; Ovarian Cancer; Endometrial Cancer

Keywords

breast cancer; locally advanced solid tumor; metastatic solid tumor; ovarian cancer; endometrial cancer; HR+/HER2-

Outcome Measures

Primary Outcomes (3)

• 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.

  Within first 28 days of treatment

• 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.

  12 months

• 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.

  12 months

Secondary Outcomes (2)

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

  12 months for Phase 1

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

  12 months for Phase 2

Study Arms (2)

Phase 1 INV-6452 Dose escalation

EXPERIMENTAL

Drug: INV-6452

Phase 2 INV-6452 Dose expansion

EXPERIMENTAL

Drug: INV-6452

Interventions

INV-6452 DRUG

once daily orally

Phase 1 INV-6452 Dose escalation; Phase 2 INV-6452 Dose expansion

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Have RECIST 1.1-defined measurable lesions.
• Has a life expectancy of \> 3 months.
• ECOG performance status 0-1.
• Adequate marrow, liver and kidney function.
• Meet the study's specified contraceptive requirements.

You may not qualify if:

• 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.
• Prior anti-tumor therapy-related toxicities have not recovered to protocol-specified grades.
• Diagnosed with immunodeficiency or received any form of immunosuppressive therapy within 7 days prior to the first dose.
• Patients with other severe and persistent underlying medical conditions as assessed by the Investigator.
• Have protocol-defined clinically significant cardiovascular diseases.
• Prolonged QTcF interval.
• Have any medical conditions likely to impair digestion and absorption of the investigational product.
• Patients with poorly managed blood glucose levels and blood pressure.
• Clinically significant abnormal serum potassium or sodium as judged by the investigator.
• Have experienced a severe concurrent infection 14 days prior to the first dose of study drug.
• Confirmed infection with HIV, HBV or HCV.
• Are currently receiving any other investigation agent.

Sponsors & Collaborators

• Shenzhen Ionova Life Sciences Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Ovarian Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Central Study Contacts

Yi Zhu, MD, MBA

CONTACT

1 908 240 7514; yi.zhu@ionovabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: July 4, 2025
• Primary Completion (Estimated): February 4, 2028
• Study Completion (Estimated): February 4, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)