BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors

NCT05555251 on ClinicalTrials.gov Phase 1/2 BioInvent International AB (industry) Started 2022-07-28 Terminated

Riskier than 78% of active trials

Model scores of the 29,894 trials active now.

Model score 22% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (257 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2024-02-07, after 2022-07-28 start.

Reason given by the sponsor: “business”

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-02-07. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cancersolidtumoradvancedchemotherapy
Phrases that lowered it: open labellight chaincombinationbiefficacy and
Sponsor's past termination rate: 40% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1/2 (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 12.8% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
Sponsor's past trials: 5 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Design: sequential (lowers risk) · Design
Drug's FAERS reports before start: 48914 (lowers risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join
Blinding: none (raises risk) · Design

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 1/2 (typical: 2)
Number of arms: 2
Allocation: non randomized (typical: randomized)
Design: sequential (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 2 (typical: 1)

Who can join

Minimum age: 18
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 5 (typical: 32)
Sponsor's past termination rate: 40% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 1 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 48914 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 5628 (typical: 412.5)
Drug's FAERS reports marked serious: 85.8% (typical: 85.6%)
Drug's FAERS reports with a death: 12.8% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: trastuzumab

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer NCT03983395 · started 2020 · scored riskier than 95% of active trials terminated
A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer NCT06188559 · started 2024 · scored riskier than 95% of active trials completed
Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab NCT04276493 · started 2020 · scored riskier than 66% of active trials completed
Study of ADCT-502 in Patients With Advanced Solid Tumors Withhuman Epidermal Growth Factor Receptor-2 (HER2) Expression NCT03125200 · started 2017 · scored riskier than 24% of active trials terminated
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers NCT05091528 · started 2022 · scored riskier than 70% of active trials terminated

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.