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Advanced Solid TumorPhase 1/2NCT04284488

Dose-escalation Study of APG-1387 and Toripalimab in Solid Tumors

A Phase 1/2 study testing APG-1387 for Injection and Toripalimab in people with Advanced Solid Tumor, run by Ascentage Pharma Group Inc. at 3 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

An ascending dose study in patients with solid tumors to evaluate the safety, tolerability, pharmacodynamics and efficacy of APG-1387 in combination with toripalimab. A phase II study of 3 cohorts will be included. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
APG-1387 for Injection and Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesChina
Study dates
10 Apr 2020to 30 Nov 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathologically confirmed advanced solid tumors
  • For phase II CRC group only: Patients with histologically confirmed microsatellite stable (detected by immunohistochemistry, PCR or NGS methods) advanced colorectal cancer.
  • For phase II NPC group only: Patients with histologically or cytologically confirmed advanced NPC.
  • For phase II NSCLC group only: Patients with histologically confirmed or cytologically confirmed advanced non-small cell lung cancer together with wild-type EGFR/ALK/ROS1 (first or second-generation sequencing results are allowed).
  • Patients who have failed standard antitumor therapy.
  • At least one evaluable lesion according to RECIST 1.1 criteria.
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  • Age greater than 18 years, both men and women.
  • ECOG: 0 to 1.
  • Expected survival ≥ 3 months.
  • The function of vital organs meets the following criteria (no blood components and cell growth factors are allowed 2 weeks before the start of study treatment):
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
  • Platelets ≥ 100 × 10^9/L;
  • Hemoglobin ≥ 90 g/L;
  • Serum albumin ≥ 30 g/L;
  • Total bilirubin ≤ 1.5 x the upper limit of normal(ULN), ALT and AST ≤ 2.5 x ULN; if there is liver metastasis, ALT and AST ≤ 5 x ULN;
  • Serum creatinine ≤ 1.5 x ULN ; or if Serum creatinine >1.5 x UL, 24-hour creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft-Gault formula);
  • Patients with asymptomatic brain metastases (not requiring pharmacological control) or brain metastases that have been stable for more than 28 days after treatment.
  • Patients must have recovered to Grade 1 or less from adverse reactions resulting from prior antineoplastic therapy (except alopecia and sensory neuropathy not exceeding Grade 2).
  • Males, women of childbearing potential (postmenopausal women who must have been postmenopausal for at least 12 months to be considered of non-childbearing potential) and their partners voluntarily use contraception deemed effective by the investigator during treatment and for at least three months after the last dose of study drug.
  • Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of any trial-specified study procedures.
  • Patients must be voluntary and able to complete study procedures and follow-up examinations.

Who cannot join

  • Cytotoxic chemotherapy, radiation therapy, surgery (except minor surgery), anticancer therapy with hormone therapy (except hormone for hypothyroidism or estrogen replacement therapy (ERT)), or any clinical study treatment within 28 days prior to the first dose of study drug; or clinically significant tumor embolism or tumor lysis syndrome (TLS).
  • Immunotherapy, biologic therapy or anti-TNFa therapy within 28 days or 5 half-lives (whichever is shorter) prior to receiving the first dose of study drug.
  • Patients who have received targeted therapy within 28 days prior to first dose of study drug.
  • Prior treatment with anti PD-1, anti PD-L1, or anti PD-L2 agents (Phase II CRC cohort only).
  • Patients have an immunodeficiency diagnosis or are receiving chronic systemic steroid therapy (daily dose of more than 10 mg prednisone equivalent) or any form of immunosuppressive therapy 7 days prior to the first dose of trial treatment.
  • Patients have any active autoimmune disease or a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, decreased thyroid function (can be included if hormone replacement therapy is effective); patients with vitiligo or asthma that has been completely relieved in childhood and does not require any intervention after adulthood can be included, and patients with asthma requiring bronchodilators for medical intervention cannot be included.
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  • Patient has an active infection or unexplained fever > 38.5。C within 2 weeks prior to the first dose (subjects may be enrolled due to tumor generated fever as judged by the investigator).
  • Any evidence of a past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroids, or clinically active interstitial lung disease.
  • Hepatic decompensation.
  • Evidence of any severe or uncontrolled systemic disease; various chronic active infections such as hepatitis B (evidence of hepatitis activity such as HBV-DNA ≥ 104 copies/mL or 2000 IU/mL), hepatitis C, and HIV.
  • Any of the following cardiac criteria: Mean QTc> 470 msec at rest during screening; Any clinically important abnormality in rhythm, conduction, or morphology of the resting electrocardiogram (ECG) (e.g., complete left bundle branch block, third degree heart block, second degree heart block); Congenital long QT syndrome or family history of long QT syndrome.
  • Uncontrolled hypertension (requiring 2 or more medications to control blood pressure); Unstable cardiac pain; Angina pectoris within 3 months of study entry; Congestive heart failure (NYHA class II or higher); Previous myocardial infarction (NSTEMI or STEMI) within 6 months of study entry; Serious cardiac arrhythmia requiring medical attention; Serious hepatic, renal, gastrointestinal, or metabolic disease.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to APG-1387 or toripalimab or their constituents.
  • Have received a live vaccine within 28 days prior to the first dose of investigational product. Live vaccines include but are not limited to the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacille Calmette-Guérin vaccine (BCG) and typhoid. Injectable seasonal influenza vaccines are usually inactivated viral vaccines and are therefore allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed.
  • Patients who have not sufficiently recovered after surgical treatment as judged by the investigator. Patients with major surgery within 28 days prior to the first dose of study drug and minor surgery within 7 days prior to the start of the study.
  • Pregnant or lactating female patients.
  • The subject has other factors that may cause the subject to be forced to terminate the study, such as suffering from other serious diseases (including mental illness) requiring concomitant treatment, severe abnormalities in laboratory tests, family or social factors, conditions that may affect the safety of the subject or the collection of trial data, etc.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Foshan First People's Hospital

    Foshan, Guangdong

  • Sun-Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • The Affiliated Hospital OF Guangxi Medical University

    Nanning, Guangxi, 530021

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of APG-1387 in Combination With Toripalimab in Patients With Advanced Solid Tumors

An ascending dose study in patients with solid tumors to evaluate the safety, tolerability, pharmacodynamics and efficacy of APG-1387 in combination with toripalimab. A phase II study of 3 cohorts will be included.

Read the detailed description

This study will be conducted in two phases. In phase Ib, the safety and efficacy of different dose levels of APG-1387 in combination with 240 mg toripalimab will be explored to determine the recommended Phase 2 dose (RP2D) of APG-1387 in combination therapy, both administered as a 30-minute intravenous (IV) infusion. The following proposed doses of APG-1387 are to be evaluated: 20,30, or 45mg .

The Phase II portion, will compromise 3 cohorts of 15-25 patients.

The 3 cohorts will include the following:

  • Colorectal cancer
  • Nasopharyngeal carcinoma
  • Non-small cell lung cancer with PD-1 antibody refractory or relapse.
Being tested
APG-1387 for Injection, Toripalimab

What participants receive

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

  • APG-1387 for InjectionDrug

    APG-1387 IV on Days 1 and 8 of each 21-Day Cycle. The following doses of APG-1387 to be studied: 20, 30, and 45mg. In the phase II, the assigned recommended phase two dose will be administered in all cohorts.

  • ToripalimabDrug

    Also called JS001

    240 mg toripalimab IV on Day 1 of each 21-Day Cycle

Study groups in NCT04284488
Study groupRoleWhat they receive
APG-1387 in combination with ToripalimabExperimentalNot described
Receives: Drug: APG-1387 for Injection; Drug: Toripalimab

What is being measured

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

  1. Recommended Phase 2 dose(RP2D) (Applicable for: phase I stage in various solid tumor types).

    Recommended phase 2 dose(RP2D) of APG-1387 in combination with toripalimab in subjects with solid tumors.

    Measured: 21 days.

  2. Disease control rate (Applicable for: phase II in cohorts of Colorectal Cancer, Nasopharyngeal Carcinoma and Non-Small Cell Lung Cancer) .

    Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) Version1.1 and iRECIST.

    Measured: 18-24months.

Secondary outcomes (2)

  1. Overall Response (Applicable for: phase I stage in various solid tumor types)

    Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and iRECIST.

    Measured: 18-24months.

  2. Incidence of Treatment-Emergent Adverse Events (safety and tolerability) (Applicable for: phase II)

    Patients treatment related adverse events (AEs) and severe adverse events (SAEs) will be assessed according NCI CTCAE Version 5.0.

    Measured: 18-24months.

Timeline

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

  1. First posted25 Feb 2020
  2. Study start10 Apr 2020
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Why it stopped: Company Strategy

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04284488
Sponsor's protocol ID
APG1387XC101
Status last verified
Jan 2026
First submitted
5 Feb 2020
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
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 APG-1387 for Injection and Toripalimab in people with Advanced Solid Tumor, run by Ascentage Pharma Group Inc. at 3 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 21 inclusion and 17 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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: Company Strategy). 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?

Recommended Phase 2 dose(RP2D) (Applicable for: phase I stage in various solid tumor types). (time frame: 21 days.). The study lists 2 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 NCT04284488.

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 8 Jan 2026.

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