A study to test the safety and effects of IOMX-0675, an antibody treatment, alone or with pembrolizumab, in patients with advanced or spreading solid tumors that have already been treated (LIMNOS)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

iOmx Therapeutics AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-04-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Pharmacodynamic, Dose response

Identify the Recommended Phase II Dose of IOMX-0675 in monotherapy and in combination with pembrolizumab.

Secondary objectives 1

1. Assess the clinical activity of IOMX-0675 monotherapy and combination therapy with pembrolizumab

Conditions and MedDRA coding

Advanced/metastatic solid tumors

Regulatory references

Scientific advice from competent authorities

Danish Medicines Agency

Plan to share IPD

Yes

IPD plan description

Time Frame: Data requests can be submitted starting 9 months after publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Age ≥ 18 years (or legal age of consent in the country) at the time of signing the informed consent form
2. Cytologically or pathologically confirmed locally advanced, inoperable, and/or metastatic cancer
3. All subjects must have received at least one previous line of systemic therapy for the tumor type under investigation
4. ECOG Performance Status of 0 or 1
5. For male subjects with female partners of childbearing potential and female subjects of childbearing potential: agreement to use contraception during treatment and for ≥ 3 months after the last dose of IOMX-0675
6. Recovery from all toxicities of previous anti-cancer therapy (including radiotherapy) to Grade ≤ 1 or stable Grade 2 (NCI CTCAE v5), except for alopecia, asymptomatic endocrinopathies, or toxicities managed with stable replacement therapy (e.g., hypothyroidism, adrenal insufficiency)
7. Adequate organ function within 7 days prior to the first IMP administration, as assessed by: a) ANC ≥ 1200/µL b) Platelets ≥ 75,000/µL c) Hemoglobin ≥ 9 g/dL d) Total bilirubin ≤ 1.5×ULN (or ≤ 3.0×ULN for Gilbert's disease) e) AST and ALT ≤ 3.0×ULN (≤ 5.0×ULN with hepatic metastases) f) Albumin WNL g) eGFR ≥ 50 mL/min (CKD-EPI formula) h) No transfusions, substitutions, or stimulating factors within 2 weeks prior to blood testing
8. At least one evaluable lesion by iRECIST criteria (backfill cohorts of monotherapy and all combination cohort)
9. Willingness and ability to undergo serial tumor biopsies (baseline and post-baseline) (backfill cohorts of monotherapy and all combination cohort)
10. For monotherapy backfill cohorts: histologically confirmed: a) non-small cell lung cancer (NSCLC) treated with a cytotoxic systemic regimen, immune checkpoint inhibitor and/or targeted therapy, or b) gastric or gastro-esophageal junction cancer treated with a fluoropyrimidine containing systemic regimen, or c) mesothelioma treated with a cytotoxic systemic regimen and/or immune checkpoint inhibitor, or d) kidney cancer (RCC) treated with a targeted (anti-angiogenic) and/or immune checkpoint inhibitor therapy.
11. For combination cohorts: histologically and molecularly confirmed advanced or metastatic MSS or pMMR colorectal cancer having received one prior line of therapy containing a fluoropyrimidine-containing regimen AND anti-angiogenetic and/or anti-EGFR therapy.

Exclusion criteria 15

1. Significant uncontrolled cardiovascular disease or NYHA class III or IV cardiac insufficiency
2. Pregnancy or breastfeeding
3. Known symptomatic CNS metastases and/or carcinomatous meningitis a) Exception: stable, previously treated brain metastases (no progression on MRI for ≥ 4 weeks, no neurologic symptoms at baseline, no steroids for ≥ 7 days prior to study medication) b) Patients eligible for complete surgical resection of brain metastases are excluded
4. History of significant cerebrovascular disease (e.g., stroke) within 6 months or Grade ≥ 3 sensory/motor neuropathy
5. Treatment with anti-cancer or investigational drugs within 5 half-lives or 30 days prior to first drug administration (whichever is shorter)
6. Pregnancy or breastfeeding
7. Known symptomatic CNS metastases and/or carcinomatous meningitis a) Exception: stable, previously treated brain metastases (no progression on MRI for ≥ 4 weeks, no neurologic symptoms at baseline, no steroids for ≥ 7 days prior to study medication) b) Patients eligible for complete surgical resection of brain metastases are excluded
8. Active autoimmune disease or syndrome requiring systemic steroids or immunosuppressants, except for: a) Inhaled corticosteroids b) History of autoimmune disease not requiring systemic treatment for ≥ 2 years (except autoimmune-induced thyroid dysfunction) c) Vitiligo or resolved childhood asthma/atopy d) Local steroid injections e) Hypothyroidism stable on hormone replacement
9. Known or suspected hypersensitivity to IOMX-0675 or its excipients (L-histidine, L-arginine polysorbate 80)
10. History of Grade > 3 immune-related adverse events (irAEs) with prior immunotherapy
11. Unresolved toxicity > Grade 1 from prior therapies (except alopecia and toxicities managed with stable substitution therapy)
12. Clinically relevant findings on screening 12-lead ECG, per investigator judgment
13. Psychological conditions potentially compromising trial compliance, per investigator judgment
14. History of pneumonitis or interstitial lung disease (combination cohorts only)
15. More than four prior lines of systemic therapy (for backfill monotherapy and combination cohorts only)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 8

1. Identification of a RP2D and combination dose of IOMX-0675 based on the comparative integration of this information across dose levels:
2. • Incidence of DLTs attributable to IOMX-0675 and pembrolizumab, where applicable, at each dose level and identification of a maximum tolerated dose (MTD).
3. • Type, incidence, and severity of treatment related AEs according to the NCI CTCAE version 5.0 at each dose level.
4. • Calculation of at least the following parameters: Cmax, tmax, AUClast, t½ from concentration time information.
5. • Maximum receptor occupancy
6. Dose selection will be further supported by:
7. • Observed clinical activity (see secondary endpoints)
8. • Biomarker activity

Secondary endpoints 3

1. Overall response rate (ORR)
2. Duration of Response (DoR)
3. Progression free survival (PFS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

iOmx Therapeutics AG

Sponsor organisation

iOmx Therapeutics AG

Address

Fraunhoferstrasse 22, Martinsried Martinsried

City

Planegg

Postcode

82152

Country

Germany

Scientific contact point

Organisation

iOmx Therapeutics AG

Contact name

Tiantom Jarutat

Public contact point

Organisation

iOmx Therapeutics AG

Contact name

Stephanie Koelbl

Third parties 11

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications