Cancer
This first-in-human (FIH) study is planned to evaluate the safety, tolerability, pharmacokinetics (PK), efficacy, immunogenicity, and pharmacodynamics of IOS-1002 as monotherapy and as combination therapy with a PD-1 monoclonal antibody (mAb)-pembrolizumab in subjects with advanced solid tumors.
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 pembrolizumab with advanced solid tumors
- Part B (Phase 1b, monotherapy cohort expansion): IOS-1002 alone with advanced solid tumors
- Part C (Phase 1b, combination therapy cohort expansion): IOS-1002 plus pembrolizumab with advanced solid tumors.
- Category
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Trial status
Not yet recruiting
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Trial phase
Phase 1 Drug TrialEarly stage studies seeking initial evidence of safety, dosage and efficacy in small numbers of patients or healthy volunteers.
- Registry listing
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ERM Project ID
91005
Trial contact details
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Contact person
Dr Catherine Shannon
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Phone
07 3163 6174
What you need to know
Who can take part?
- Histologically or cytologically confirmed advanced solid tumor (metastatic and/or unresectable) with measurable disease per RECIST v1.1:
- For subjects participating in Part A (monotherapy and combination therapy dose-escalation), 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 enroll provided the lesions have demonstrated clear progression and can be measured accurately.
- For Part A (combination therapy dose-escalation) and Part C (combination therapy cohort expansion) only: Subjects are eligible for this part of the study if:
- The subject is PD-1/PD-L1 treatment naive, or
- The subject has been continuously exposed to PD-1/PD-L1 treatment for at least 6 months, and has developed disease progression on continued anti-PD-1/PD-L1 treatment, and has not had a Grade ≥3 irAE requiring discontinuation of PD-1/PD-L1 treatment. Subjects progressing under PD-1/PD-L1 first line treatment should have first received standard of care second line treatment (such as chemotherapy in tumor proportion score 50+ NSCLC subjects, if indicated). Once subjects fail second line treatment, they would qualify for the study as long as they fulfil the previously mentioned criteria.
- Subjects who have received prior therapy with any agent specifically targeting T-cell co-stimulation pathways such as anti-GITR antibody, anti-CD137, anti-OX40 antibody must have a washout period of greater than 4 weeks from the last treatment to first dose of study treatment.
- Palliative radiotherapy must have been completed at least 2 weeks prior to first dose.
- Adequate organ function at Screening (Please contact Study doctor for more information).
What is involved for you?
Subjects will undertake a Screening visit between Day −30 and Day −1 to determine their eligibility in the study. After Screening, all eligible subjects will be enrolled to receive IOS-1002 Q2W administered alone or in combination with pembrolizumab Q6W as IV infusions.
During the study, subjects will undergo assessments for evaluation of safety and toxicity, PK, pharmacodynamics, immunogenicity, and antitumor activity of IOS-1002 as monotherapy or in combination with pembrolizumab using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at predefined time points. Subjects will have an End-of-Treatment (EOT)/Early Termination (ET) visit within 30 days after the last scheduled dose of study treatment or until the resolution of symptoms (as applicable).
Thereafter, subjects will be followed up for survival until lost to follow-up, death, or withdrawal of informed consent, or the 12-month survival data of the last subject has been collected (whichever is earliest).
Trial dates
March 2024 - March 2026
