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Solid TumorPhase 1NCT03053466

APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors

A Phase 1 study testing APL-501 in people with Solid Tumor and Microsatellite Instability, run by Apollomics (Australia) Pty. Ltd. at 5 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the safety, tolerability, and recommended dose schedule of APL-501 in individuals with advanced or relapsed or recurrent solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
APL-501
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesAustralia
Study dates
27 Mar 2017to 25 Feb 2022
Phase
Phase 1
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

Major Inclusion Criteria:

  • Able to understand and comply with study procedures, understand the risks involved, and provide written informed consent.

Dose Escalation:

  • Histologically and / or cytological confirmed solid tumors: colorectal, endometrial, gastric including, gastroesophageal junction adenocarcinoma (GC), head and neck (esophageal, hepatocellular (HCC), non-small cell lung cancer, mesothelioma, ovarian, and renal cell carcinoma (RCC), either refractory or relapsed to standard therapy or for which no effective standard therapy is available.
  • No restriction to number of prior therapies for Dose Escalation Segment except for gastric and renal cell carcinoma.

Cohort Extension:

  • Histologically and/or cytological confirmed solid tumors with an approved labelled indication for PD-1 inhibitors.
  • Tumor biopsy at study entry and during therapy. Tumor sites used to satisfy this criterion must not have received any prior radiation therapy. Sites for biopsy must be distinct from target lesions used for efficacy assessment.
  • Measurable disease according to RECIST v1.1.

Dose and Disease Expansion:

  • MSI-H or dMMR per local laboratory and failed at least one prior line of standard of care chemotherapy per local standards.
  • Carcinoma of Unknown Primary

Major Exclusion Criteria:

  • History of severe hypersensitivity to mAbs, excipients of the drug product or other components
  • Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast
  • Any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy
  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-stimulation pathways) (except NSCLC)
  • Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the Investigator, predisposes the subject to high risk of noncompliance with the protocol treatment or assessments.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Cabrini Health Limited

    Malvern, Victoria, 3144

  • Peter MaCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Nucleus Network

    Melbourne, Victoria, 3004

  • Linear Clinical Research

    Nedlands, Western Australia, 6009

Other trials in Australia

About this study

Official title: A Phase 1 Multicenter, Dose Escalation, Cohort Extension and Dose and Disease Expansion Study of APL-501 in Subjects With Select Advanced or Relapsed/Recurrent Solid Tumors

The purpose of this study is to determine the safety, tolerability, and recommended dose schedule of APL-501 in individuals with advanced or relapsed or recurrent solid tumors.

Read the detailed description

This is a Phase 1, multicenter, 3-part study with a Dose-Escalation Segment, Cohort Extension and Dose and Disease Expansion cohorts of APL-501 injection, a humanized IgG4 monoclonal antibody, targeting the Programmed Death-1 (PD-1) membrane receptor on T lymphocytes and other cells of the immune system. Select advanced solid tumor malignancies will receive escalating doses of APL-501.

Dose escalation will occur in three subject cohorts until a protocol defined dose limited toxicity (DLT) occurs, not due to disease progression or inter-current illness, and a tentative maximum tolerated dose (MTD) or biologically effective dose (BED) is determined.

Cohort Extension will evaluate APL-501 at 3 mg/kg and 10 mg/kg on Day 1 and Day 15 every 28 days.

At the tentative MTD, BED or recommended Phase 2 dose (RP2D), at least two tumor types in the Dose and Disease Expansion will be assessed at an equivalent non-weight based dose to further evaluate toxicity and preliminary efficacy.

Being tested
APL-501
Keywords
Advanced Solid Tumor, Relapsed Solid Tumor, Recurrent Solid Tumor
Medical subject headings
Microsatellite Instability, Turcot syndrome, Neoplasms, Unknown Primary

What participants receive

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

  • APL-501Drug

    Also called GB226, genolimzumab

    Subjects will be assigned to a dose level in the order of study entry. Treatment includes a minimum of four 28-day cycles at three planned dose levels (1, 3, and 10 mg/kg). In the Dose Escalation Segment, each treatment cycle is comprised of 2 doses of study drug administered on Days 1 and 15 of a 28-day cycle. In the Cohort Extension, the treatment cycle will consist of 2 doses of study drug administered on Days 1 and 15 of a 28-day cycle.

    In Dose and Disease Expansion, the treatment cycle will consist of 2 doses of study drug (non-weight based dosing of 400 mg) administered on Days 1 and 15 of a 28-day cycle.

Study groups in NCT03053466
Study groupRoleWhat they receive
Single-ArmExperimentalAPL-501
Receives: Drug: APL-501

What is being measured

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

  1. Number of participants with treatment related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4.03) in patients with advance solid tumors

    Adverse events, serious adverse events, dose limiting toxicities according to the National Cancer Institute (NCI) Terminology Criteria for Adverse Events (CTCAE v4.03)

    Measured: From the time of informed consent from signature until Day 28 after Cycle 1; Dose Escalation - Approximately 9 months

Secondary outcomes (9)

  1. Determine the recommended Phase 2 dose and schedule

    adverse events, serious adverse events, dose limiting toxicities

    Measured: An average of 1 year

  2. Area under the plasma concentration versus time curve (AUC)

    AUC, 0-infinity

    Measured: Up to 4 months (1 cycle = 28 days)

  3. Maximum plasma concentration

    Cmax

    Measured: Up to 4 months (1 cycle = 28 days)

  4. Time to reach Cmax

    Tmax

    Measured: Up to 4 months (1 cycle = 28 days)

  5. Objective Response Rate (ORR)

    The treatment effect of APL-501 will be assessed by RECIST v1.1 and by irRECIST to determine proportion of patients with complete response or partial response.

    Measured: Approximately 24 months

  6. Duration of Response (DOR)

    The treatment effect of APL-501 will be assessed by RECIST v1.1 or by irRECIST to determine duration of response. Time from first documented complete response or partial response until subsequent documented disease progression or death.

    Measured: Approximately 24 months

  7. Time to Response (TTR)

    The treatment effect of APL-501 will be assessed by RECIST v1.1 and by irRECIST to determine time to complete response and partial response.

    Measured: Approximately 24 months

  8. Disease Control Rate (DCR)

    The treatment effect of APL-501 will be assessed by RECIST v1.1 and irRECIST to determine disease control rate. Proportion of patients with best overall response of complete response, partial response, or stable disease.

    Measured: Approximately 24 months

  9. Progression Free Survival

    The effect of APL-501 will be assessed by RECIST v1.1 and per irRECIST to determine progression free survival as time from date of first dose to date of disease progression or death.

    Measured: Approximately 24 months

Timeline

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

  1. First posted15 Feb 2017
  2. Study start27 Mar 2017
  3. Primary completion25 Feb 2022
  4. Study completion25 Feb 2022

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03053466
Sponsor's protocol ID
APL-501-01
Status last verified
May 2022
First submitted
30 Jan 2017
Last updated
9 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing APL-501 in people with Solid Tumor and Microsatellite Instability, run by Apollomics (Australia) Pty. Ltd. at 5 sites in Australia.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of participants with treatment related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4.03) in patients with advance solid tumors (time frame: From the time of informed consent from signature until Day 28 after Cycle 1; Dose Escalation - Approximately 9 months). 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 NCT03053466.

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 9 May 2022.

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