Trial Review

COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03053466




Registration number
NCT03053466
Ethics application status
Date submitted
30/01/2017
Date registered
15/02/2017
Date last updated
10/09/2020

Titles & IDs
Public title
APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors
Scientific 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
Secondary ID [1] 0 0
APL-501-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Microsatellite Instability 0 0
Mismatch Repair Deficiency 0 0
Cancer of Unknown Primary Site 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - APL-501

Experimental: Single-Arm - APL-501


Treatment: Drugs: APL-501
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
From the time of informed consent from signature until Day 28 after Cycle 1; Dose Escalation - Approximately 9 months
Secondary outcome [1] 0 0
Determine the recommended Phase 2 dose and schedule - adverse events, serious adverse events, dose limiting toxicities
Timepoint [1] 0 0
An average of 1 year
Secondary outcome [2] 0 0
Area under the plasma concentration versus time curve (AUC) - AUC, 0-infinity
Timepoint [2] 0 0
Up to 4 months (1 cycle = 28 days)
Secondary outcome [3] 0 0
Maximum plasma concentration - Cmax
Timepoint [3] 0 0
Up to 4 months (1 cycle = 28 days)
Secondary outcome [4] 0 0
Time to reach Cmax - Tmax
Timepoint [4] 0 0
Up to 4 months (1 cycle = 28 days)
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Approximately 24 months
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Approximately 24 months
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Approximately 24 months
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Approximately 24 months
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Approximately 24 months

Eligibility
Key inclusion criteria
Major

• 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Peter MaCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
Nucleus Network - Melbourne
Recruitment hospital [3] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Apollomics (Australia) Pty. Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Apollomics Inc. (formerly CBT Pharmaceuticals, Inc.)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT03053466
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Fabio Benedetti, MD
Address 0 0
Chief Medical Officer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shelly McCurry, MS
Address 0 0
Country 0 0
Phone 0 0
(650) 209-4055
Fax 0 0
Email 0 0
shelly.mccurry@apollomicsinc.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03053466