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Outcome Measures

Primary Outcomes (4)

[Phase 1a dose escalation] Determine Recommended Dose Range
RDR determination: between the minimal reproducibly active dose and the maximum tolerated dose or maximum administered dose. Based on the totality of the data including toxicity/tolerability, efficacy, PK, and PD
Approximately 12 months
[Phase 1a dose escalation] Incidence of Treatment-Emergent Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, and ≥grade 3 laboratory abnormalities.
Type, frequency, and severity of TEAEs according to NCI Common Terminology Criteria for Adverse Events Version 5.0 criteria.
Throughout study completion, approximately 12 months
[Phase 1b Recommended Phase 2 Dose selection] Determine the RP2D
RP2D determination: The Safety Monitoring Committee will determine the RP2D based on the totality of the data including overall safety, pharmacokinetic, pharmacodynamic, and preliminary antitumor activity including the percentage of patients with PR or CR based on RECIST Version 1.1.and duration of response.
Approximately 12 months
[Phase 2 dose expansion] Evaluate preliminary antitumor activity
ORR defined as the percentage of patients with PR or CR based on RECIST Version 1.1.
Approximately 12 months

Secondary Outcomes (18)

[Phase 1a, Phase 1b, Phase 2] observed maximum plasma concentration after administration [Cmax]
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] time to reach the observed maximum (peak) concentration [Tmax]
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] area under the plasma concentration-time curve from time zero to dosing interval [AUC0-τ]
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] Area under the concentration-time curve from time zero to the time with last measurable concentration [AUC0-t]
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] area under the concentration-time curve from time zero extrapolated to infinity [AUC0-∞]
Up to Cycle 2 Day 2 (each cycle is 21 days)
+13 more secondary outcomes

Study Arms (3)

Phase 1a; Dose escalation at various dose levels in patients with EGFR TKI sensitizing mutation

EXPERIMENTAL

Drug: BBT-207

Phase 1b; At 2 recommended dose levels of BBT-207 in patients with EGFR C797S mutation

EXPERIMENTAL

Drug: BBT-207

Phase 2; At the recommended phase 2 dose of BBT-207 in patients with EGFR C797S mutation

EXPERIMENTAL

Drug: BBT-207

Interventions

BBT-207Drug

BBT-207 given orally alone

Phase 1a; Dose escalation at various dose levels in patients with EGFR TKI sensitizing mutationPhase 1b; At 2 recommended dose levels of BBT-207 in patients with EGFR C797S mutationPhase 2; At the recommended phase 2 dose of BBT-207 in patients with EGFR C797S mutation

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Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically or cytologically confirmed Stage III (locally advanced) NSCLC not amenable to curative therapy or stage IV NSCLC.
Patients must have received treatment with at least 1 third-generation EGFR TKI (eg, Osimertinib, Lazertinib).

First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (18)

Study Arms (3)

Phase 1a; Dose escalation at various dose levels in patients with EGFR TKI sensitizing mutation

Phase 1b; At 2 recommended dose levels of BBT-207 in patients with EGFR C797S mutation

Phase 2; At the recommended phase 2 dose of BBT-207 in patients with EGFR C797S mutation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (18)

Study Arms (3)

Phase 1a; Dose escalation at various dose levels in patients with EGFR TKI sensitizing mutation

Phase 1b; At 2 recommended dose levels of BBT-207 in patients with EGFR C797S mutation

Phase 2; At the recommended phase 2 dose of BBT-207 in patients with EGFR C797S mutation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations