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A Study to Evaluate the Safety and Preliminary Signs of Efficacy of [177Lu]Lu-OncoFAP-23 Alone or in Combination With L19-IL2 as a Treatment of Metastatic FAP-positive Solid Tumors

ConditionFAP
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhilogen S.p.A.

About this trial

The aim of this study is to assess the safety of \[177Lu\]Lu-OncoFAP-23 alone or in combination with L19-IL2 for the treatment of advanced/metastatic Fibroblast Activation Protein (FAP)-positive solid tumors and to establish a Recommended Dose (RD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with advanced/metastatic solid tumors, who have progressed on available standard treatments.

Patients with FAP-positive tumors as evaluated by [68Ga]Ga-OncoFAP-DOTAGA-PET/CT imaging.

Patients without other therapeutic alternatives with curative or survival prolonging potential as per investigator judgement.

Male or non-pregnant and non-breast feeding female, age 18 or more.

Disqualifiers

Any cancer therapy within 4 weeks of study entry.

Active or history of autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.

Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Iodine-131, Lutetium-177 conjugates or hemi-body irradiation within 6 months prior to enrollment.

White blood cell count (WBC) minor than 2.5 x 109/L, absolute neutrophil count (ANC) minor than 1.5 x 109/L, platelets minor than 100 x 109/L or hemoglobin (Hb) minor than 9.0 g/dl,

Trial design

Design model

Sequential

Treatments tested in this trial

  • [177Lu]Lu-OncoFAP-23

    Drug

    3.7, 7.4, or 11.1 GBq to define the RD

  • L19IL2

    Drug

    22.5 Mio IU

Treatment groups

56 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Part I - Dose Escalation - Cohort 1, Arm 1Experimental treatment 1 intervention
Group B: Part I - Dose Escalation - Cohort 2, Arm 1Experimental treatment 1 intervention
Group C: Part I - Dose Escalation - Cohort 3, Arm 1Experimental treatment 1 intervention
Group D: Part I - Dose Escalation - Cohort 4, Arm 2Experimental treatment 2 interventions
Group E: Part I - Dose Escalation - Cohort 5, Arm 2Experimental treatment 2 interventions
Group F: Part II - Dose Expansion - Arm 1Experimental treatment 1 intervention
Group G: Part II - Dose Expansion - Arm 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicity

Dose Limiting Toxicity (DLT)

Time frame
From Day 1 to 28 of the dose escalation part
2

Maximum Tolerated Dose (MTD) and Recommended Dose (RD)

Maximum Tolerated Dose (MTD) and Recommended Dose (RD)

Time frame
From Day 1 to 28 of the dose escalation part
3

Maximum Administered Dose (MAD)

Maximum Administered Dose (MAD)

Time frame
From Day 1 to 28 of the dose escalation part
4

Adverse Events (AEs) and Serious Adverse Events (SAEs)

Adverse events (AEs) and Serious Adverse Events (SAEs) assessment based on Common Terminology Criteria for Adverse Events v. 5.0 (CTCAE)

Time frame
through study completion, maximum 1 year

Secondary outcomes

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
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