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Phase I Study Evaluating 161Tb-PSMA Therapy in Adult Patients With Metastatic Clear Cell Renal Cell Carcinoma

ConditionMetastatic Clear Cell Renal Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCentre Leon Berard

About this trial

This study is an open label, Phase I study investigating the safety and clinical activity of 4 IV injections of 161Tb-PSMA-1 in patients with mccRCC.

This trial is divided in 2 parts:

* The dose escalation part aims to assess the safety of 161Tb-PSMA-1 in up to 21 patients with mccRCC. Eligible patients will be treated with escalating activity of 161Tb-PSMA. * The extension part aims to collect preliminary clinical activity data of the proposed treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

I1. Male or female patients aged ≥ 18 years at time of informed consent signature.

I2. Patient with histologically confirmed diagnosis of metastatic clear cell renal cell carcinoma (mccRCC) progressing during or after at least 2 lines of therapy including at least 1 line of anti-VEGFR and 1 line of immunotherapy.

I3. Patient with documented radiological disease progression at the time of inclusion with measurable disease as per RECIST v1.1.

For patient with only extrahepatic disease: ≥ 50% of positive extrahepatic lesions

Disqualifiers

E1. Patients with known active central nervous system (CNS) metastases and/or epidural metastases and/or leptomeningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to C1D1 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids (at doses higher than 10 mg/d of methylprednisolone or equivalent) for at least 4 weeks prior to C1D1.

E2. Patients previously treated with any radiopharmaceutical.

E3. Persisting AEs related to previous anti-cancer therapy which were not resolved to grade ≤ 1 (except: anemia provided that criterion I7 is met) and /or any persistent immune-related AEs >1 (except adequately controlled irAE, e.g.: with replacement therapy for endocrine irAE) using NCI CTCAE V6.0.

E4. History, within 2 years, of cancer other than renal cancer, except for basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or localized prostate cancer.

Trial design

Design model

Single group

Treatments tested in this trial

  • 161Tb-PSMA-1 (radiopharmaceutical)

    Drug

    161Tb-PSMA-1 (from 7.4 GBq ± 10% to 11.5GBq ± 10%), intravenously (IV) for 4 cycles administered every 6 weeks. Dose Levels 161Tb-PSMA, IV, Q6W, 4 doses * DL-1 5.5 GBq ± 10% Q6W * DL1 (starting activity) 7.4 GBq ± 10% Q6W * DL2 9.5 GBq ± 10% Q6W * DL3 11.5 GBq ± 10% Q6W

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: 161Tb-PSMA-1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Dose-limiting toxicities (DLT)

Time frame
During the first cycle of treatment (i.e., first 6 weeks)

Secondary outcomes

1

Objective Response Rate at 24 weeks (ORR-24W)

Time frame
24 weeks after treatment start
2

Objective Response Rate (ORR)

defined as the rate of patients with a complete or partial response (CR or PR) according to RECIST v1.1.

Time frame
Assessed through study completion, an average of 12 months.
3

Disease Control Rate after 24 weeks (DCR24w)

Time frame
24 weeks after treatment start
4

Best Overall Response Rate (BORR)

Time frame
Assessed through study completion, an average of 12 months.

Other outcomes

Sponsors and contacts

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

Centre Leon Berard

Lead sponsor

Source ClinicalTrials.gov

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