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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)Sarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadiopharm Theranostics, Ltd

About this trial

This is a Phase 1/2a dose escalation and expansion study to determine the safety, tolerability, and preliminary clinical activity of 177LuBetaBart, a lutetium-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

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.

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.

Must have at least 1 measurable target lesion according to RECIST v1.1.

Disqualifiers

History of prior organ transplant.

Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer.

Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures.

Residual toxicity ≥ Grade 2 from prior anti-cancer therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • 177Lu-BetaBart

    Drug

    177Lu-BetaBart administered intravenously (IV) every 6 weeks at escalating doses

  • BetaBart + unlabeled BetaBart

    Drug

    177Lu-BetaBart + unlabeled BetaBart administered intravenously (IV) every 6 weeks at escalating doses

Treatment groups

61 Participants
are divided into 1 treatment group
Group A: Escalating doses of 177 Lu-BetaBart with or without BetaBart every 6 weeksExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety and Tolerability of 177LuBetaBart

TEAEs as defined by CTCAE v5.0

Time frame
6 weeks
2

To assess the preliminary anti-tumor activity of 177Lu-BetaBart at the RP2D

ORR per RECIST v1.1 and iRECIST

Time frame
Up to 30 weeks
3

To assess preliminary anti-tumor activity, as defined by biochemical response, in CRPC participants at the RP2D

Proportion of participants who achieve a best response of PSA50

Time frame
Up to 30 weeks

Secondary outcomes

1

To assess the preliminary anti-tumor activity of 177Lu-BetaBart

ORR per RECIST v1.1 and iRECIST

Time frame
Up to 30 weeks
2

To assess preliminary anti-tumor activity, as defined by biochemical response, in CRPC participants

Proportion of participants who achieve a best response of PSA50

Time frame
Up to 30 weeks
3

Assess biodistrubution, PK, and radiation dosimetry of 177Lu-BetaBart

Absorbed Radiation doses in critical organs

Time frame
6 weeks
4

Effect of Co-injection of unlabeled BetaBart on biodistribution of radiolabeled 177Lu-BetaBart

Absorbed Radiation doses in critical organs

Time frame
6 weeks

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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