BridgeMD
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)
EU CTIS ID: 2024-517449-14-00
What this study is testing
Identify the Recommended Phase II Dose of IOMX-0675 in monotherapy and in combination with pembrolizumab.
- Human Pharmacology (Phase I)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years (or legal age of consent in the country) at the time of signing the informed consent form
- 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.
- 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.
- Cytologically or pathologically confirmed locally advanced, inoperable, and/or metastatic cancer
- All subjects must have received at least one previous line of systemic therapy for the tumor type under investigation
- ECOG Performance Status of 0 or 1
You likely can't join if
- Significant uncontrolled cardiovascular disease or NYHA class III or IV cardiac insufficiency
- History of Grade > 3 immune-related adverse events (irAEs) with prior immunotherapy
- Unresolved toxicity > Grade 1 from prior therapies (except alopecia and toxicities managed with stable substitution therapy)
- Clinically relevant findings on screening 12-lead ECG, per investigator judgment
- Psychological conditions potentially compromising trial compliance, per investigator judgment
- History of pneumonitis or interstitial lung disease (combination cohorts only)
See the full eligibility criteria
Who can join
- Age ≥ 18 years (or legal age of consent in the country) at the time of signing the informed consent form
- 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.
- 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.
- Cytologically or pathologically confirmed locally advanced, inoperable, and/or metastatic cancer
- All subjects must have received at least one previous line of systemic therapy for the tumor type under investigation
- ECOG Performance Status of 0 or 1
- 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
- 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)
- 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
- At least one evaluable lesion by iRECIST criteria (backfill cohorts of monotherapy and all combination cohort)
- Willingness and ability to undergo serial tumor biopsies (baseline and post-baseline) (backfill cohorts of monotherapy and all combination cohort)
What rules you out
- Significant uncontrolled cardiovascular disease or NYHA class III or IV cardiac insufficiency
- History of Grade > 3 immune-related adverse events (irAEs) with prior immunotherapy
- Unresolved toxicity > Grade 1 from prior therapies (except alopecia and toxicities managed with stable substitution therapy)
- Clinically relevant findings on screening 12-lead ECG, per investigator judgment
- Psychological conditions potentially compromising trial compliance, per investigator judgment
- History of pneumonitis or interstitial lung disease (combination cohorts only)
- More than four prior lines of systemic therapy (for backfill monotherapy and combination cohorts only)
- Pregnancy or breastfeeding
- 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
- History of significant cerebrovascular disease (e.g., stroke) within 6 months or Grade ≥ 3 sensory/motor neuropathy
- Treatment with anti-cancer or investigational drugs within 5 half-lives or 30 days prior to first drug administration (whichever is shorter)
- Pregnancy or breastfeeding
- 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
- 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
- Known or suspected hypersensitivity to IOMX-0675 or its excipients (L-histidine, L-arginine polysorbate 80)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.