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Advanced Solid TumorsPhase 1/2REACHNCT05010525

A Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG 016 Monotherapy in Patients With Advanced Solid Tumors

A Phase 1/2 study testing ATG-016 in people with Advanced Solid Tumors, run by Shanghai Antengene Corporation Limited at 4 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is A Phase Ib/II Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG 016 Monotherapy in Patients with Advanced Solid Tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
ATG-016
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
4 sitesChina
Study dates
1 Sep 2021to 14 Nov 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Understand and voluntarily sign informed Consent (ICF) prior to any assessment/procedure related to study.
  • Age ≥18 years at ICF signature.
  • Estimated life expectancy of minimum of 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.
  • Subjects must have at least one measurable lesion as defined by RECIST version 1.1.
  • Females of childbearing potential must agree to use effective contraception from the time ICF signature until 180 days after the last dose. Females of childbearing potential include those who are premenopausal and those who are 2 years postmenopausal. Blood pregnancy tests must be negative for female of childbearing potential must have a negative serum pregnancy test at Screening.
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  • Inclusion Criteria Only for Phase Ib study (Dose Escalation and Expansion phase)
  • 1. Histological or cytological confirmation of a solid tumor, and have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have no standard therapy(ies) exists.
  • Penile squamous cell carcinomas confirmed by cytology or histology cannot be excised by radical surgery, or postoperative recurrence or metastasis which is not suitable for platinum chemotherapy or platinum resistance or platinum failure.
  • Nasopharyngeal carcinoma

Who cannot join

  • Subjects with any of the following conditions will not be enrolled in this study.
  • Central nervous system (CNS) metastases and involvement.
  • A history of bone marrow or organ transplantation.
  • Prior ATG-016 administration or other XPO1 inhibitor treatment.
  • Known to be allergic to the active or inactive ingredients of ATG-016 or drugs with similar chemical structure, or the subject is hypersensitive.
  • Prior therapy with any investigational drugs or systemic anticancer treatment (eg, a period of 5 'half-lives' of drugs, whichever is longer) within 28 days at the time of ICF signature.
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  • Received extensive radiation within 28 days at the time of ICF signature or expect to undergo radical radiotherapy during the study period.
  • Received major surgery within 28 days at the time of ICF signature or expect to proceed a major surgical treatment during the study period.
  • Any toxicities unresolved to Grade 1 or baseline from prior anti-tumor therapy (According to NCI-CTCAE 5.0) with the exception of alopecia, within 28 days at the time of ICF signature.
  • Any uncontrolled active infection requiring parenteral treatment of antibiotics, antivirals, or antifungals at the time of ICF signature or within one week of Cycle 1 Day 1 (C1D1). Active hepatitis B virus (HBV) infection (Hepatitis B surface antigen [HBsAg] positive) or active HCV infection (HCV-RNA positive at screening).
  • A history of HIV infection and/or acquired immunodeficiency syndrome.
  • Received immunosuppressive medication within 14 days at the time of ICF signature.
  • Cardiovascular diseases of clinical significance
  • Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
  • Have a history of another primary malignancy within 5 years prior to starting study treatment, with following exceptions: malignancy tumors treated by radical therapy and have not been recurred, such as carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, papillary thyroid carcinoma, etc.
  • Inability or unwillingness to comply with the requirement for oral drug administration, or presence of a gastrointestinal diseases or other clinical conditions that would compromise the absorption of study drug, eg, refractory nausea and vomiting, inability to swallow the formulated product, or previous significant bowel resection, etc.
  • Active or a history of bleeding within 6 months.
  • Received any live attenuated vaccination within 28 days at the signature of ICF.
  • Judgment by the investigator that the subject should not participate in the study by consideration of the complications or other conditions which might affect their adherence to the protocol.
  • Female subjects who are pregnant or lactating.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • The First Affiliated Hospital of Bengbu Medical College Bengbu

    Bengbu, Anhui, 233099

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610044

  • Chongqing Cancer Hospital

    Chongqing, Chonqing, 400000

  • The First Affiliated Hospital of Xiamen University

    Xiaomen, Fujian, 361000

Other trials in China

About this study

Official title: A Phase Ib/II Open-label, Multi-centre, Dose Finding Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG 016 Monotherapy in Patients With Advanced Solid Tumors

This is A Phase Ib/II Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG 016 Monotherapy in Patients with Advanced Solid Tumors

Read the detailed description

This is A Phase Ib/II Open-label, Multi-centre, Dose Finding Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG 016 Monotherapy in Patients with Advanced Solid Tumors

Being tested
ATG-016

What participants receive

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

  • ATG-016Drug

    48 patients enrolled, orally, each 3 week (21-day) a cycle

Study groups in NCT05010525
Study groupRoleWhat they receive
ATG-016-20mgExperimental20 mg QD×5/ week as the initial dose in the Dose Escalation Phase, with a treatment cycle of 21 days,1-5/week will be the initial dose of this study
Receives: Drug: ATG-016
ATG-016-35mgExperimental35 mg QD×5/ week as the initial dose in the Dose Escalation Phase, with a treatment cycle of 21 days,1-5/week will be the initial dose of this study
Receives: Drug: ATG-016
ATG-016-50mgExperimental50 mg QD×5/ week as the initial dose in the Dose Escalation Phase, with a treatment cycle of 21 days,1-5/week will be the initial dose of this study
Receives: Drug: ATG-016
ATG-016-65mgExperimental65 mg QD×5/ week as the initial dose in the Dose Escalation Phase, with a treatment cycle of 21 days,1-5/week will be the initial dose of this study
Receives: Drug: ATG-016

What is being measured

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

  1. MTD in Phase I

    MTD will be evaluated using the NCI-CTCAE, Version 5.0

    Measured: 16 months

  2. RP2D in Phase I

    RP2D will be determined under the guidance of the SRC.

    Measured: 16 months

  3. AEs

    Toxicity will be graded according to the NCI CTCAE, Version 5.0.

    Measured: 25 months

  4. SAEs

    Toxicity will be graded according to the NCI CTCAE, Version 5.0.

    Measured: 25 months

  5. ORR in Phase II

    Based on 2006 IWG Response Criteria, evaluated by IRC: ORR (CR + PR + mCR)

    Measured: 25 months

Secondary outcomes (3)

  1. Disease Control Rate (DCR) in Phase I/II

    DCR (CR + PR + mCR + HI + SD)

    Measured: 16 months

  2. Duration of Response (DOR) in Phase I/II

    To evaluate duration of response

    Measured: 12 months

  3. Overall Survival (OS）

    The estimates of Kaplan-Meier

    Measured: 12 months

Timeline

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

  1. First posted18 Aug 2021
  2. Study start1 Sep 2021
  3. Primary completion14 Nov 2022
  4. Study completion14 Nov 2022

Why it stopped: Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study

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
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05010525
Sponsor's protocol ID
ATG-016-ST-001
Acronym
REACH
Status last verified
Jul 2022
First submitted
11 Aug 2021
Last updated
17 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ATG-016 in people with Advanced Solid Tumors, run by Shanghai Antengene Corporation Limited at 4 sites in China.

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 10 inclusion and 20 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: stopped early, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in 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?

The study was stopped early (reason given: Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the 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?

MTD in Phase I (time frame: 16 months). The study lists 5 primary outcomes in all. 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 NCT05010525.

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 17 Mar 2023.

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