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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05763004




Registration number
NCT05763004
Ethics application status
Date submitted
9/01/2023
Date registered
10/03/2023

Titles & IDs
Public title
A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IOS-1002 Administered Alone and in Combination with Pembrolizumab, a PD-1 Monoclonal Antibody in Advanced Solid Tumors
Scientific title
A Phase 1a/1b, First-in-human, Open-label, Non-randomized, Multicenter, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Efficacy, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of IOS 1002 Administered Alone and in Combination with Pembrolizumab, a PD-1 Monoclonal Antibody in Advanced Solid Tumors
Secondary ID [1] 0 0
KEYNOTE-F49 / MK-3475-F49
Secondary ID [2] 0 0
IOS-1002-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor, Adult 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IOS-1002
Treatment: Drugs - IOS-1002 + KEYTRUDA® (pembrolizumab)

Experimental: IOS-1002 Monotherapy -

Experimental: IOS-1002 Combination Therapy with KEYTRUDA® (pembrolizumab) -


Treatment: Drugs: IOS-1002
monotherapy

Treatment: Drugs: IOS-1002 + KEYTRUDA® (pembrolizumab)
combination therapy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the incidence of treatment emergent Adverse Events (Safety and Tolerability) of various doses of IOS-1002 administered alone and/or in combination with a PD-1 mAb in subjects with advanced solid tumors
Timepoint [1] 0 0
From date of randomization until the date of first documented progression (end of study) or date of death from any cause, whichever came first, assessed up to 48 months
Secondary outcome [1] 0 0
To investigate the preliminary antitumor activity of IOS-1002 and in combination with a PD-1 mAb
Timepoint [1] 0 0
From date of randomization until the date of first documented progression (end of study) or date of death from any cause, whichever came first, assessed up to 48 months
Secondary outcome [2] 0 0
To characterize the PK of IOS-1002 alone and in combination with a PD-1 mAb
Timepoint [2] 0 0
From date of randomization until the date of first documented progression (end of study) or date of death from any cause, whichever came first, assessed up to 48 months
Secondary outcome [3] 0 0
To characterize the immunogenicity of IOS-1002 alone and in combination with a PD-1 mAb
Timepoint [3] 0 0
From date of randomization until the date of first documented progression (end of study) or date of death from any cause, whichever came first, assessed up to 48 months
Secondary outcome [4] 0 0
To characterize the immunogenicity of IOS-1002
Timepoint [4] 0 0
From date of randomization until the date of first documented progression (end of study) or date of death from any cause, whichever came first, assessed up to 48 months

Eligibility
Key inclusion criteria
1. Age =18 years old at the time of Screening (signing the informed consent form [ICF]).
2. Histologically or cytologically confirmed advanced solid tumor (metastatic and/or unresectable) with measurable disease per RECIST v1.1:

1. Malignancy that has relapsed or is refractory to, at least 1 standard treatment regimen in the advanced or metastatic setting, if such a therapy exists or for which the subjects who refuse or are ineligible for standard therapy.
2. Subjects with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enrol provided the lesions have demonstrated clear progression and can be measured accurately.
3. For combination therapy dose-escalation: subjects who have undergone treatment with any agent specifically targeting checkpoint pathway inhibition (such as PD-1, PD-L1, PDL-2, LAG-3, or CTLA-4 antibody) for at least 3 months before disease progression and must have a gap of at least 4 weeks from the last treatment before receiving study treatment on Cycle 1 Day 1

a. Subjects who experienced prior Grade 1 to 2 checkpoint therapy-related immune mediated AEs must have confirmed recovery from these events at the time of study entry, other than endocrinopathies treated with supplementation. Where applicable, these subjects must also have completed steroid tapers for treatment of these AEs by a minimum of 14 days prior to commencing treatment with study therapy. b) Eligibility of subjects with prior Grade =3 checkpoint therapy-related immune AEs, will be considered on a case-by-case basis after discussion with the Medical Monitor (eg, asymptomatic isolated Grade 3 lipase elevations without clinical or radiological features of pancreatitis will be permitted to enrol).
4. Adequate organ function at Screening
5. Willingness to provide consent to allow the acquisition of fresh tumor biopsy and/or existing formalin tissue sample
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded. EXCEPTION: Subjects with controlled brain metastases will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), and off steroids for at least 4 weeks prior to Screening, and no new or progressive neurological signs and symptoms.
2. Subjects with known carcinomatous meningitis.
3. Subjects with a prior malignancy except non-melanoma skin cancers, and in situ cancers such as: bladder, colon, cervical/dysplasia, melanoma, or breast. Subjects with other second malignancies diagnosed more than 2 years ago who have received therapy with curative intent with no evidence of disease during the interval who are considered by the Investigator to present a low risk for recurrence will be eligible.
4. Subjects with active, known, or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, euthyroid with a history of Grave's disease (subjects with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid-stimulating immunoglobulin prior to first dose of study treatment), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
5. Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity, including subjects with pneumonitis.
6. Chronic Obstructive Pulmonary Disease (COPD) requiring recurrent steroids bursts or chronic steroids at doses greater than 10 mg/day of prednisone or the equivalent.
7. Uncontrolled or significant cardiovascular disease
8. Evidence of active infection =7 days prior to initiation of study treatment therapy (does not apply to viral infections that are presumed to be associated with the underlying tumor type required for study entry).
9. Evidence or history of active or latent tuberculosis infection including purified protein derivative recently converted to positive; chest x-ray with evidence of infectious infiltrate.
10. History of any chronic hepatitis
11. Known history of testing positive for HIV or known acquired immunodeficiency syndrome. Note: Testing for HIV must be performed at Screening.
12. Any anticancer therapy (eg, chemotherapy, biologics, vaccines, or hormonal treatment) including investigational drugs within 4 weeks prior to the first dose of study treatment administration, except for GnRH agonist therapy for subjects with prostate cancer and anticancer therapies with half-life of <4 weeks eg, prior use of EGFR TKI (completed at least two weeks prior to first dose of study treatment is acceptable).
13. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration except for adrenal replacement steroid doses >10 mg daily prednisone equivalent in the absence of active autoimmune disease. Note: Treatment with a short course of steroids (<5 days) up to 7 days prior to initiating study treatment is permitted.
14. Use of non-oncology vaccines containing live virus for prevention of infectious diseases within 12 weeks prior to study treatment. The use of inactivated seasonal influenza vaccines eg, Fluzone® will be permitted on study without restriction.
15. Any major surgery within 4 weeks of study treatment administration. Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study treatment.
16. Prior organ allograft.
17. Use of packed red blood cells (pRBC) or platelet transfusion within 2 weeks prior to the first dose of study treatment.
18. History of allergy to PD-1 mAb, significant drug allergy (such as anaphylaxis or hepatotoxicity) to prior anticancer immune modulating therapies (eg, checkpoint inhibitors, T-cell costimulatory antibodies).
19. All toxicities attributed to prior anticancer therapy other than alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE v5.0) or baseline before administration of study treatment. Subjects with toxicities attributed to prior anticancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum-based therapy, are permitted to enroll.
20. Subjects with known HLA alloimmunization (not specifically tested for the trial)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
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
15/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Health Medical Center - Clayton
Recruitment hospital [2] 0 0
Austin Health / Cancer Clinical Trials Center - Heidelberg
Recruitment hospital [3] 0 0
Alfread Health - Melbourne
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment hospital [5] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ImmunOs Therapeutics AG
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Claudia Berger
Address 0 0
Country 0 0
Phone 0 0
+41792025755
Fax 0 0
Email 0 0
claudia.berger@immunostherapeutics.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05763004