Assessing an Oral SERD, DZD3969 in Patients With Advanced ER+HER2- Breast Cancer (MU-LAN1)

Breast Neoplasms Clinical Trial

Official title:

A Phase I/II, Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of DZD3969 as Monotherapy or in Combination With Palbociclib in Postmenopausal Female Patients With Estrogen Receptor Positive (ER+) and HER2 Negative (HER2-) Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04277468
• Other study ID #: DZ2019ER001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: February 2020
• Est. completion date: September 2022

Study information

• Verified date: February 2020
• Source: Dizal (Jiangsu) Pharmaceutical Co., Ltd.
• Contact: Yijun Jia, M.D., Ph. D
• Phone: +86 02161095853
• Email: Yijun.Jia[@]dizalpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will treat patients with advanced ER+HER2- breast cancer who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with this new drug. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as alone and in combination with Palbociclib

Description:

A Phase I/II, Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of DZD3969 as Monotherapy or in Combination with Palbociclib in Postmenopausal Female Patients with ER+ HER2- Breast Cancer. This study includes dose escalation part, dose expansion part and combination expansion part.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: September 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older;

• Patients with histologically or cytologically confirmed diagnosis of breast cancer with evidence of metastatic or locally advanced disease, not amendable to resection or radiation therapy with curative intent;

• ER positive and/or PgR positive of recurrent, metastatic and/or primary tumor tissue;

• Negativity of HER2 of recurrent, metastatic and or primary tumor tissue;

• Part B: Patients must have progressed on or after at least one line, but no more than 3 lines of endocrine therapy and no more than 2 lines of chemotherapy for locally advanced/metastatic disease. Prior treatment must have included CDK4/6 inhibitors.

Exclusion Criteria:

• Prior treatment with chemotherapy within 4 weeks before screening;

• Radiotherapy with a limited field for palliation within 1 week of the first dose of study treatment;

• Symptomatic and/or life-threatening visceral metastases, including diffuse lymphangitic carcinomatosis, bulky liver or pulmonary metastases;

• Part B: Treatment with fulvestrant within 90 days;

• Part C: Prior treatment with chemotherapy, immunotherapy, endocrine therapy or any investigational drugs.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• DZD3969
Daily dose of DZD3969, except for cycle 0 of Part A, in which a single dose of DZD3969 is administrated. Starting dose of DZD3969 is 40 mg twice daily. If tolerated, subsequent cohorts will test increasing doses of DZD3969.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dizal (Jiangsu) Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).	To investigate the safety and tolerability of DZD3969 as monotherapy when given orally to postmenopausal female patients with locally advanced or metastatic ER+ HER2- breast cancer who have relapsed from prior standard therapy; To define maximum tolerated dose (MTD) (if possible) of DZD3969	28 days after the first multiple dose
Primary	Part B and Part C: Recommended Phase II Dose (RP2D) and Recommended Phase II Combination Dose (RP2CD); Anti-tumor efficacy as monotherapy or in combination with Palbociclib	To define Recommended Phase II Dose (RP2D) of DZD3969 as monotherapy in patients with locally advanced or metastatic ER+ HER2- breast cancer who have progressed from prior endocrine therapy and Recommended Phase II Combination Dose (RP2CD) of DZD3969 in combination with Palbociclib in patients with locally advanced or metastatic ER+ HER2- breast cancer without any prior therapy ; To assess anti-tumor efficacy of DZD3969 as monotherapy or in combination with Palbociclib according to RECIST version 1.1	Through the study completion, an average of around 1 year
Secondary	Plasma DZD3969 concentration	To characterize the pharmacokinetics (PK) of DZD3969 following a single oral dosing, and at steady state after multiple oral dosing as monotherapy at selected doses of DZD3969	At the end of Cycle 3 Day 1 (7 days for cycle 0, 28 days for each subsequent cycle)