Solid Tumor, AdultPhase 1NCT05763004
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
A Phase 1 study testing IOS-1002 and IOS-1002 + KEYTRUDA® (pembrolizumab) in people with Solid Tumor, Adult, run by ImmunOs Therapeutics AG at 5 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- IOS-1002 and IOS-1002 + KEYTRUDA® (pembrolizumab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 5 sitesAustralia
- Study dates
- 15 Mar 2023to 30 May 2026
- 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
Who may be able to join
- Age ≥18 years old at the time of Screening (signing the informed consent form [ICF]).
- Histologically or cytologically confirmed advanced solid tumor (metastatic and/or unresectable) with measurable disease per RECIST v1.1:
- 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.
- 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.
- 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
- 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).
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- Adequate organ function at Screening
- Willingness to provide consent to allow the acquisition of fresh tumor biopsy and/or existing formalin tissue sample
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Who cannot join
- 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.
- Subjects with known carcinomatous meningitis.
- 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.
- 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.
- 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.
- Chronic Obstructive Pulmonary Disease (COPD) requiring recurrent steroids bursts or chronic steroids at doses greater than 10 mg/day of prednisone or the equivalent.
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- Uncontrolled or significant cardiovascular disease
- 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).
- 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.
- History of any chronic hepatitis
- Known history of testing positive for HIV or known acquired immunodeficiency syndrome. Note: Testing for HIV must be performed at Screening.
- 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).
- 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.
- 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.
- 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.
- Prior organ allograft.
- Use of packed red blood cells (pRBC) or platelet transfusion within 2 weeks prior to the first dose of study treatment.
- 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).
- 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.
- Subjects with known HLA alloimmunization (not specifically tested for the trial)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Monash Health Medical Center
Clayton
Austin Health / Cancer Clinical Trials Center
Heidelberg
Alfread Health
Melbourne
Peter MacCallum Cancer Center
Melbourne
Linear Clinical Research
Perth
About this study
Official 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
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:
Read more
- 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.
- Conditions
- Solid Tumor, Adult
- Being tested
- IOS-1002, IOS-1002 + KEYTRUDA® (pembrolizumab)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOS-1002Drug
monotherapy
IOS-1002 + KEYTRUDA® (pembrolizumab)Drug
combination therapy
| Study group | Role | What they receive |
|---|---|---|
| IOS-1002 Monotherapy | Experimental | Not described Receives: Drug: IOS-1002 |
| IOS-1002 Combination Therapy with KEYTRUDA® (pembrolizumab) | Experimental | Not described Receives: Drug: IOS-1002 + KEYTRUDA® (pembrolizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Incidence of any Adverse Event DLTs AEs leading to study treatment discontinuationAEs leading to study discontinuation Abnormal laboratory parameters, vital signs, ECOG performance status, ECG results, and physical examination
Measured: 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 outcomes (4)
To investigate the preliminary antitumor activity of IOS-1002 and in combination with a PD-1 mAb
Investigator-assessed treatment response as defined and summarized by RECIST v1.1 and/or iRECIST
Measured: 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
To characterize the PK of IOS-1002 alone and in combination with a PD-1 mAb
Concentrations of IOS-1002 in plasma
Measured: 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
To characterize the immunogenicity of IOS-1002 alone and in combination with a PD-1 mAb
Number of subjects with ADA.
Measured: 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
To characterize the immunogenicity of IOS-1002
Percentage of subjects with ADA
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start15 Mar 2023
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunOs Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763004
- Sponsor's protocol ID
- IOS-1002-201
- Other IDs
- KEYNOTE-F49 / MK-3475-F49
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05763004
- Acronym / sponsor ID
- IOS-1002-201
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- ImmunOs Therapeutics AGIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOS-1002 Monotherapy | Experimental | Drug: IOS-1002 |
| IOS-1002 Combination Therapy with KEYTRUDA® (pembrolizumab) | Experimental | Drug: IOS-1002 + KEYTRUDA® (pembrolizumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years old at the time of Screening (signing the informed consent form [ICF]).
- Histologically or cytologically confirmed advanced solid tumor (metastatic and/or unresectable) with measurable disease per RECIST v1.1:
- 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
- Adequate organ function at Screening
- Willingness to provide consent to allow the acquisition of fresh tumor biopsy and/or existing formalin tissue sample
Key exclusion criteria (20 listed)
- 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.
- Subjects with known carcinomatous meningitis.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOS-1002monotherapy | Drug | IOS-1002 Monotherapy |
| IOS-1002 + KEYTRUDA® (pembrolizumab)combination therapy | Drug | IOS-1002 Combination Therapy with KEYTRUDA® (pembrolizumab) |
Primary outcome
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
Time frame: 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
Incidence of any Adverse Event DLTs AEs leading to study treatment discontinuationAEs leading to study discontinuation Abnormal laboratory parameters, vital signs, ECOG performance status, ECG results, and physical examination
4 secondary outcomes
To investigate the preliminary antitumor activity of IOS-1002 and in combination with a PD-1 mAb
Time frame: 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
To characterize the PK of IOS-1002 alone and in combination with a PD-1 mAb
Time frame: 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
To characterize the immunogenicity of IOS-1002 alone and in combination with a PD-1 mAb
Time frame: 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
To characterize the immunogenicity of IOS-1002
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IOS-1002 and IOS-1002 + KEYTRUDA® (pembrolizumab) in people with Solid Tumor, Adult, run by ImmunOs Therapeutics AG 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?
The sponsor lists 9 inclusion and 20 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: finished, as of the sponsor's last update on 26 Jun 2026. 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?
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 (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2026.