A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer

ConditionAdvanced or Metastatic Breast Cancer

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexFemale

Age18+

SponsorKind Pharmaceuticals LLC

About this trial

This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 \[HER2\]-negative) breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Postmenopausal women defined as NCCN guideline at the time of informed consent.

Histological or cytological confirmation of advanced or metastatic ER+/HER2- breast cancer women who failed standard therapy or for which no standard therapy exists.

No more than 1 line of chemotherapy for advanced breast cancer

Recurrence or progression on at least one line of endocrine therapy in the advanced or metastatic disease setting and derived a clinical benefit from the endocrine therapy: Recurred or progressed while being treated with adjuvant endocrine therapy for a duration of at least 24 months, or progressed under endocrine therapy for more than 6 months in the advanced or metastatic setting

Disqualifiers

Previous treatment with any SERDs.

Patient any central nervous system metastasis.

Received chemotherapies within 3 weeks before the first dose.

Received systemic radiotherapy within 3 weeks before the first dose, or local radiotherapy within 7 days before the first dose

Trial design

Design model

Sequential

Treatments tested in this trial

AND019 PO QD
Drug
AND019 administrated as oral capsule once per day for 28 days for each cycle

Treatment groups

61 Participants

are divided into 1 treatment group

Group A: AND019 single dose escalation and expansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Number of participants with adverse events by severity, according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0

Number of participants with adverse events

Time frame

From baseline to 12 weeks after the last dose of study treatment (up to 25 months)

PK study of AND019

Plasma concentration of AND019 over time

Time frame

At predefined timepoints at Day 1, Day 8, Day 15, and Day 22 of Cycle 1, and Day 1 of each cycle starting from Cycle 2 (each cycle is 28 days)

Secondary outcomes

Determine the RP2D

To observe the dose limiting toxicity (DLT) and maximum tolerated dose MTD to determine RP2D.

Time frame

From baseline to up to the end of Cycle 1 (each cycle is 28 days)

Percentage of Participants with Objective Response

ORR is defined as a complete response or partial response on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1)

Time frame

Baseline and every 8 weeks from Cycle 1 Day 1 until Week 24, and then every 12 weeks until end of study treatment (up to 24 months) (each cycle is 28 days)

Clinical Benefit Rate

CBR is defined as the percentage of participants achieving either of the following: confirmed complete response or partial response (as determined by the investigator according to RECIST v1.1); or the first occurrence of progressive disease after 24 weeks of study treatment.

Time frame

Baseline and every 8 weeks from Cycle 1 Day 1 until Week 24 (each cycle is 28 days)

Duration of Response

DoR is defined as the percentage of participants achieving either of the following: confirmed complete response or partial response.

Time frame

From the first occurrence of a documented objective response until first observation of disease progression or death from any cause on study, whichever occurs first (up to 24 months)

Other outcomes

Progression free survival

PFS is defined as the time from treatment start date until objective tumor progression (PD) or death whichever comes first

Time frame

From treatment start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

PD study of AND019 in blood samples

Change from baseline in therapy resistant markers by liquid biopsy

Time frame

At predefined timepoints at baseline, Cycle 1 Day 15, Cycle 2 Day 1, and End of Treatment (up to 2 years) (each cycle is 28 days).

PD study of AND019 in tissue samples

Change from baseline in therapy resistant markers by tissue biopsy

Time frame

At predefined timepoints at baseline and between Cycle 2 Day 1 to Cycle 3 Day 28 (each cycle is 28 days)