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A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in Patients With Advanced Solid Tumors

ConditionsRenal Carcinoma MetastaticPancreatic Adenocarcinoma MetastaticPancreatic AdenocarcinomaMetastatic Colorectal Carcinoma (mCRC)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPhilogen S.p.A.

About this trial

This trial aims to address unmet medical needs in advanced solid tumors, specifically metastatic clear cell renal carcinoma, locally advanced or metastatic pancreatic adenocarcinoma, and metastatic colorectal adenocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

at least one prior line containing FOLFIRINOX and/or gemcitabine plus nab-paclitaxel, and

at least one approved second-line regimen (e.g., 5-FU/leucovorin plus liposomal irinotecan), or where these regimens are not suitable due to contraindication or prior intolerance

at least one prior line of systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan, with or without anti-VEGF and, if RAS wild-type, with or without anti-EGFR, and

at least one approved subsequent line of therapy with trifluridine-tipiracil, regorafenib or fruquintinib, or where these agents are not suitable due to contraindication or prior intolerance;

Disqualifiers

Patients with primary brain tumors, brain metastases or CNS disease will be excluded.

Chemotherapy, immunotherapy, or radiation therapy at the tumor sites within 4 weeks prior to study treatment start.

Active or history of autoimmune disease that might deteriorate when receiving an immunostimulatory agent.

Previous or concurrent cancer type that is distinct from the cancer being evaluated in this study. Exception made for any other cancer curatively treated ≥ 2 years prior to study treatment start.

Trial design

Design model

Sequential

Treatments tested in this trial

  • L19IL2

    Drug

    Intravenous administration

  • Ruxolitinib

    Drug

    10 mg twice, oral administration

Treatment groups

96 Participants
are divided into 3 treatment groups
Group A: Experimental L19IL2 dose escalation intravenous administrationExperimental treatment 1 intervention
Group B: Experimental L19IL2 + Ruxolitinib dose escalation intravenous administrationExperimental treatment 2 interventions
Group C: Experimental L19IL2 + Ruxolitinib dose expansion intravenous administrationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

STEP A and STEP B: DLT

Occurrence of Dose Limiting Toxicity (DLT) of L19IL2 alone and in combination with ruxolitinib

Time frame
From Day 1 to Day 28 of the treatment
2

Safety (AE)

Adverse Events (AEs) of administration of L19IL2 alone and in combination with ruxolitinib, assessed by Common Toxicity Criteria (version 5.0, CTCAE)

Time frame
Through study completion, an average of 1 year
3

Safety (SAEs)

Serious Adverse Events(SAEs) of administration of L19IL2 alone and in combination with ruxolitinib, assessed by Common Toxicity Criteria (version 5.0, CTCAE)

Time frame
Through study completion, an average of 1 year
4

Safety (DILI)

Evaluation of possible Drug Induce Liver Injury (DILI), caused by L19IL2 alone and in combination with ruxolitinib, assessed by Common Toxicity Criteria (version 5.0, CTCAE)

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Overall Response Rate (ORR)

Overall Response Rate (ORR, including CR and PR) as per RECIST 1.1

Time frame
Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)
2

Disease Control Rate (DCR)

Disease Control Rate (DCR, including CR, PR, and SD) as per RECIST 1.1

Time frame
Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)
3

DoR

Duration of Response (DoR)

Time frame
Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)
4

PSF

Progression Free Survival (PFS)

Time frame
Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Philogen S.p.A.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: