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Breast CancerPhase 1/2NCT04946864

A Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination for Breast Cancer

A Phase 1/2 study testing APG-2575 and Palbociclib in people with Breast Cancer and Solid Tumor, Adult, run by Ascentage Pharma Group Inc. at 7 sites in 2 countries.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This is a multi-center, open-label, phase Ib/II study of APG-2575 as a single agent in patients with advanced solid tumors or in combination with anti-cancer agents such as CDK 4/6 inhibitor palbociclib in patients with ER+/HER2- metastatic breast cancer (mBC) who have progressed or relapsed after first line therapy Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Breast Cancer, Solid Tumor, Adult
What is being tested?
APG-2575 and Palbociclib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
7 sitesin 2 countries
Study dates
13 Aug 2021to 1 Oct 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years. 2. Histologically or cytologically confirmed solid tumors; These locally advanced or metastatic diseases have no standard effective therapy available as judged by the investigator. 3. For the patients with breast cancer:
  • Must have histological or cytological confirmation of metastatic carcinoma of the breast (either from the primary or metastatic site), with the following tumor molecular characteristics (as determined from pre-screening testing):
  • ER positive.
  • HER2 negative - non-amplified (per ASCO/CAP guidelines).
  • Must have been treated with CDK4/6 inhibitor in the metastatic setting. And the patients must have experienced disease progression during or recurrence after CDK4/6 inhibitor therapy, which must have been administered for a minimum of 8 weeks prior to progression.
  • Must have measurable disease (according to RECIST v1.1) or evaluable disease. Boneonly metastases are allowed.
Show all 15Show fewer
  • Physiological postmenopausal, defined as:
  • Age ≥60 years, or
  • Age <60 years and undergone bilateral oophorectomy or medically confirmed ovarian failure, or
  • Age <60 years and have cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have serum levels of estradiol and FSH within the reference range for postmenopausal females.
  • Premenopausal treated with LHRH analogues APG2575XU103 Version 1.0. / March 8, 2021 APG-2575 Ascentage Pharma Group Inc. Confidential Page 51 of 108 4. ECOG ≤ 1. 5. Adequate organ and bone marrow function within 14 days prior to registration:
  • 1) Hemoglobin ≥ 90 g/L. 2) Absolute neutrophil count ≥ 1.5 x 109
  • L. Note: Use of growth-factors to maintain ANC criterion is not permitted 3) Platelet count ≥ 100 x 109
  • L. Note: Use of transfusions or thrombopoietic agents to achieve baseline platelet count criterion is prohibited. 4) ALT and AST ≤ 3 x upper limit of normal (ULN), or ≤ 5 x ULN if liver metastases are present. 5) Total serum bilirubin ≤ 1.5 x ULN. Patient's with Gilbert's syndrome may have a total serum bilirubin > 1.5 x ULN. 6) Serum creatinine ≤ 1.5 x upper limit of normal (ULN); if serum creatinine is >1.5 X ULN, creatinine clearance must be ≥ 50 mL/min (Cockcroft-Gault). 6. Female patients with childbearing potential must have negative urine or serum pregnancy test within 14 days prior to registration. 7. Able to swallow whole tablets. 8. Willingness to use contraception that is deemed effective for the patients with child bearing potential (postmenopausal women must have been amenorrhea for at least 12 months to be considered of non-childbearing potential) and their partners throughout the treatment period and for at least three months following the last dose of study drug.
  • 9. Brain metastases with clinically controlled neurologic symptoms. 10. Able to sign written informed consent with willingness and ability to comply with study procedures and follow-up examination. 11. Patient assigned to combination therapy, must provide sufficient archival tumor lesion or willing to provide fresh biopsy if no archival tissue available and core or excisional biopsy of a tumor lesion where feasible. Patients cannot provide a fresh biopsy (e.g. inaccessible or patient safety concern) may be eligible upon agreement from the sponsor. -

Who cannot join

  • Receive any anti-cancer therapy within 14 days prior to the first dose of study drug, including chemotherapy, radiation therapy, surgery, targeted therapy, steroid therapy, endocrine therapy or other investigational therapy with the exception of hormones for hypothyroidism or estrogen replacement therapy (ERT) for non-breast cancer patients, or has had tumor embolization. Patients must have a 5x half-lives wash out time period or 14 for small molecules or 28 days for biologics including IO agents, gene or cellular therapeutic agents, respectively.
  • These following therapies are permitted:
  • Bisphosphonate or denosumab therapy for patients with bone metastases. APG2575XU103 Version 1.0. / March 8, 2021 APG-2575 Ascentage Pharma Group Inc. Confidential Page 52 of 108 b. Ovarian suppression in pre- and peri-menopausal patients. c. Palliative radiotherapy. 2. Receive any following agents within 14 days prior to the first dose of study drugs:
  • Strong CYP3A inhibitors or inducers
  • Drugs that are known to prolong the QT interval. 3. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to < Grade 2, exception being clinically insignificant toxicities of prior chemo/radiation such as lymphocytopenia or electrolyte abnormalities. 4. Pregnant or lactating. 5. Have a major surgery within 28 days from study entry, or have had minor surgery within 7 days of study entry. 6. Active symptomatic pathogenic infection including fungal, bacterial and/or viral infection including, but not limited to, active human immunodeficiency virus (HIV) or viral hepatitis (B or C) or active COVID-19. (Patients that have received a COVID-19 vaccination will be considered as eligible for the study.) 7. Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry. Patients with a QTc ≥ 480 msec (based on the mean value of the triplicate ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes 8. Prior use of a Bcl-2 inhibitor. 9. Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study. -

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States4 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Next Oncology

    Austin, Texas, 78229

  • MD Anderson

    Houston, Texas, 77030

  • Next Oncology

    San Antonio, Texas, 78229

Other trials in United States

China3 sites

  • Sun Yat-Sen Memorial Hospital Sun Yat-Sen University

    Guangdong, Guangzhou

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong

  • Cancer Hospital of The University of Chinese Academy of Sciences

    Hangzhou, Zhejiang

Other trials in China

About this study

Official title: A Phase Ib/II Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination With Systemic Anti-cancer Agents in Patients With ER Positive Breast Cancer or Advanced Solid Tumors.

This is a multi-center, open-label, phase Ib/II study of APG-2575 as a single agent in patients with advanced solid tumors or in combination with anti-cancer agents such as CDK 4/6 inhibitor palbociclib in patients with ER+/HER2- metastatic breast cancer (mBC) who have progressed or relapsed after first line therapy

Read the detailed description

The phase Ⅰb is dose escalation of APG-2575 as a single agent or in combination with palbociclib. A standard 3+3 design will be used to determine the MTD of APG-2575 as single agent in patients with solid tumors and MTD and RP2D of APG-2575 in combination with palbociclib in patients with breast cancer (MTD-combo). The phase II portion is a signal seeking expansion of APG-2575 at RP2D in combination with palbociclib in patients with ER+/HER2- metastatic breast cancers who have progressed during or relapsed after CDK 4/6inhibitor therapy. The phase Ⅱ portion will be conducted based on Simon's Minimax two stage design.

Being tested
APG-2575, Palbociclib
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APG-2575Drug

    Also called APG2575

    APG2575 monotherapy

  • PalbociclibDrug

    combination APG2575+pablociclib

Study groups in NCT04946864
Study groupRoleWhat they receive
single armExperimentalAPG2575
Receives: Drug: APG-2575
combination armExperimentalAPG2575+palbociclib i
Receives: Drug: APG-2575; Drug: Palbociclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT

    assessment of DLT for single and combination arm

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2021
  2. Study start13 Aug 2021
  3. Primary completion12 Aug 2024
  4. Study completion1 Oct 2024 (estimated)

Why it stopped: Company Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
3+3 cohort
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04946864
Sponsor's protocol ID
APG2575XU103
Status last verified
Aug 2024
First submitted
23 Jun 2021
Last updated
19 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing APG-2575 and Palbociclib in people with Breast Cancer and Solid Tumor, Adult, run by Ascentage Pharma Group Inc. at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04946864.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.

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Clinical Trial NCT04946864 | AzTrials