Trial 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
NCT ID:
NCT05763004
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IOS-1002
Description:
monotherapy
Arm group label:
IOS-1002 Monotherapy
Intervention type:
Drug
Intervention name:
IOS-1002 + KEYTRUDA® (pembrolizumab)
Description:
combination therapy
Arm group label:
IOS-1002 Combination Therapy with KEYTRUDA® (pembrolizumab)
Summary:
The goal of this clinical trial is to learn about IOS-1002 in patients with solid tumors.
The main questions it aims to answer are:
- To determine the safety and tolerability of various doses of IOS-1002 administered
alone and/or in combination with KEYTRUDA® (pembrolizumab) in a single dose
escalation scheme
- To determine the safety, tolerability and efficacy of a selected dose of IOS-1002
administered every 2 weeks alone and in combination with a PD-1 Antibody
The study will be conducted in 3 parts:
- Part A (Phase 1a, monotherapy and combination therapy dose escalation): IOS-1002
alone and IOS-1002 plus PD-1 mAb in patients with advanced solid tumors
- Part B (Phase 1b, monotherapy cohort expansion): IOS-1002 alone in patients with
advanced solid tumors
- Part C (Phase 1b, combination therapy cohort expansion): IOS-1002 plus PD-1 mAb in
patients with advanced solid tumors.
Criteria for eligibility:
Criteria:
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.
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Monash Health Medical Center
Address:
City:
Clayton
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Sophia Frentzas, Dr
Facility:
Name:
Austin Health / Cancer Clinical Trials Center
Address:
City:
Heidelberg
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Hui Gan, Dr
Facility:
Name:
Alfread Health
Address:
City:
Melbourne
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Ben Markman, Dr
Facility:
Name:
Peter MacCallum Cancer Center
Address:
City:
Melbourne
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Stephen Luen, Dr
Facility:
Name:
Linear Clinical Research
Address:
City:
Perth
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Michael Millward, Prof
Start date:
March 15, 2023
Completion date:
May 31, 2025
Lead sponsor:
Agency:
ImmunOs Therapeutics AG
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
ImmunOs Therapeutics AG
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05763004
