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177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

ConditionsCastration-Resistant Prostate Cancer (CRPC)Colorectal CancerNSCLC (Non-small Cell Lung Cancer)Ovarian CancerCervical CancerEndometrial CancerTNBC, Triple Negative Breast CancerSmall Cell Lung Cancer (SCLC )Head &Amp; Neck Squamous Cell Carcinoma (HNSCC)Esophageal Squamous Cell Carcinoma (ESCC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadiopharm Theranostics, Ltd

About this trial

A Phase 1/2a Dose Escalation and Expansion Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients with Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.

Participants ≥ 18 years of age.

Participants with a documented history of histopathologically confirmed CRPC*, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC. (Note: inclusion or

Disqualifiers

Participants must have documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or intolerant of standard of care therapy or have no standard of care therapy available that is likely to provide clinical benefit. Any number of prior treatment lines are allowed.

Must have at least 1 measurable target lesion according to RECIST v1.1. (Note: this does not apply for CRPC)

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.

Trial design

Design model

Single group

Treatments tested in this trial

  • 177Lu-BetaBart

    Drug

    BetaBart administered by intravenous (IV) infusion every 6 weeks

Treatment groups

61 Participants
are divided into 1 treatment group
Group A: 177 Lu-BetaBart - Dose escalation and Phase 2a expansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recommended dose(s) of 177Lu-BetaBart for future exploration (phase 1)

Incidence of dose-limiting toxicities (DLTs) during the 6 weeks following the first 177Lu-BetaBart injection

Time frame
6 weeks
2

Incidence of treatment emergent adverse events of 177-Lu-BetaBart (phase 1) (Safety and Tolerability)

As defined per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame
6 weeks
3

To assess the preliminary anti-tumor activity of 177Lu-BetaBart at the RP2D (phase 2a)

Objective response rates (ORR) as assessed by RECIST v1.1

Time frame
Up to 30 weeks
4

To assess preliminary anti-tumor activity, as defined by biochemical response, in CRPC participants who are treated with 177Lu-BetaBart at the RP2D (phase 2a)

Proportion of participants who achieve a best response of prostate-specific antigen (PSA)50

Time frame
Up to 30 weeks

Secondary outcomes

1

To assess the preliminary anti-tumor activity of 177Lu-BetaBart (phase 1)

Objective response rates (ORR) as assessed by RECIST v1.1

Time frame
Up to 30 weeks
2

To assess preliminary anti-tumor activity, as defined by biochemical response, in castration-resistant prostate cancer (CRPC) participants treated with 177Lu-BetaBart (phase 1)

Proportion of participants who achieve a best response of ≥50% decline in prostate-specific antigen (PSA50)

Time frame
Up to 30 weeks
3

Incidence of treatment emergent adverse events of 177-Lu-BetaBart at the RP2D (phase 2a) (Safety & Tolerability)

As defined per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame
6 weeks
4

Pharmacokinetics of 177Lu-BetaBart (phase 1)

Half-life of 177Lu-BetaBart in blood

Time frame
72 Hours

Other outcomes

Sponsors and contacts

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

Radiopharm Theranostics, Ltd

Lead sponsor

Medpace, Inc.

Collaborator

Source ClinicalTrials.gov
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