A Phase Ib/Ⅱ Study of NTQ1062 in Combination With Fulvestrant in Patients With Advanced HR Positive /HER-2 Negative Breast Cancer

NCT06172322 | Unknown Phase 1

• 1 other identifier: NTQ1062-BC-2023101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-arm phase 1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of NTQ1062 in combination with Fulvestrant in patients with locally advanced or metastatic HR positive/HER-2 negative breast cancer.

Conditions

HR Positive/HER-2 Negative Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD)

  The MTD is defined as the highest dose reached for which the incidence of DLT occurs in less than 1/3 of the subjects.

  First treatment cycle ( 28 days)

• Recommended phase 2 dose (RP2D)

  RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data.

  Through study completion, an average of 1 year

• Adverse events

  Safety and tolerability of NTQ1062 in combination with Fluvastatin. Incidence of adverse events.

  Through study completion, an average of 1 year

Secondary Outcomes (8)

• Pharmacokinetic parameters: Cmax

  At the end of Cycle 3 (each cycle is 28 days)

• Pharmacokinetic parameters: Tmax

  At the end of Cycle 3 (each cycle is 28 days)

• Pharmacokinetic parameters: AUC

  At the end of Cycle 3 (each cycle is 28 days)

• Pharmacokinetic parameters: T1/2

  At the end of Cycle 3 (each cycle is 28 days)

• Objective response rate (ORR)

  Through study completion, an average of 1 year

Study Arms (1)

NTQ1062 with Fulvestrant

EXPERIMENTAL

NTQ1062 Tablets（200-500）+ Fulvestrant（500mg)

Drug: NTQ1062 with Fulvestrant

Interventions

NTQ1062 with Fulvestrant DRUG

Drug: NTQ1062 tablet(s) ，PO，QD in cycles of 28 days (21 days on treatment followed by 7 days off treatment). Drug: Fulvestrant Injection 500mg in a 28-day cycle.

NTQ1062 with Fulvestrant

Eligibility Criteria

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

You may qualify if:

• Aged at least 18 years old at the time of informed consent.
• Premenopausal, perimenopausal, or postmenopausal women. Premenopausal and perimenopausal women must receive ovarian function suppression therapy during the study, and are willing to receive continuous treatment during the study.
• HR-positive or HER-2 negative breast cancer as histologically confirmed; metastatic or locally advanced disease that has recurred or progressed and for which, in the judgment of the investigator, curative surgery is not possible.
• ECOG score is 0-1.
• Predicted life expectancy ≥3 months.
• Patients must have adequate organ function.
• Patients must be signed written informed consent prior to admission to the study.

You may not qualify if:

• Patients have received previous treatment with Fulvestrant or Akt inhibitors.
• Patients who have received chemotherapy, biological therapy, immunotherapy, radiotherapy and other anti-tumor therapy or participated in other therapeutic clinical studies (except observational clinical studies) from 4 weeks prior to the first dose.
• Treatment with systemic corticosteroids (prednisone \> 10 mg/day or equivalent) or other immunosuppressive agents for the treatment of non-neoplastic diseases within 14 days prior to the first dose.
• Patients received strong inhibitors and/or inducers of CYP3A4 within 14 days or 5 drug half-lives prior to the first dose of study drug.
• Patients who have undergone major surgical procedures or significant traumatic injuries within 4 weeks prior to the first administration (excluding minor surgeries such as appendicitis and tumor biopsy), or who require elective surgery during the trial period and are not suitable for clinical research.
• Patients who have a history of receiving attenuated live vaccines or live vaccines within 4 weeks before the first administration, or who plan to receive such vaccines during the study period.
• Patients who have received prior hematopoietic stem cell transplantation or organ transplantation.
• The adverse reactions of previous anti-tumor therapy have not yet recovered to CTCAE 5.0 level evaluation ≤ 1 level.
• Active or uncontrolled serious infection (≥ CTCAE Grade 2) or unexplained fever \> 38.5 ℃ within 28 days prior to first dose.
• History of immunodeficiency, including positive HIV antibody test.
• Patients with active hepatitis: those with positive hepatitis B B surface antigen (HBsAg) and more copies of HBV DNA than the positive value detected by the research center; Individuals who are positive for hepatitis C virus (HCV) antibodies and have tested positive for HCV RNA.
• Syphilis screening positive Patients.
• Previous medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment, or any evidence of clinically active interstitial lung disease.
• History of serious cardiovascular and cerebrovascular diseases.
• Refractory nausea and vomiting, malabsorption syndrome, ulcerative colitis, symptomatic/inflammatory bowel disease, chronic diarrhea and intestinal obstruction and other serious gastrointestinal diseases, inability to take oral swallowing drugs, or the presence of conditions that seriously affect gastrointestinal absorption as judged by the investigator.

Sponsors & Collaborators

• Nanjing Chia-tai Tianqing Pharmaceutical: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201321, China

RECRUITING

MeSH Terms

Interventions

Fulvestrant

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Yu meng Zhou

CONTACT

86-025-85109999; zhouyumeng@njzdqt.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 15, 2023
• Study Start: December 28, 2023
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 23, 2024

Record last verified: 2023-12

Locations

CN (1)