Solid Tumor (Phase I)Phase 1NCT07797907
This Clinical Study is to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Antitumor Activity of BD200 in Participants With Advanced or Metastatic Cancer.
A Phase 1 study testing BD200 in people with Solid Tumor (Phase I), run by Biolojic Design Ltd..
Trial summary
The Phase 1 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of BD200 in adult participants with advanced solid cancers. This is an open-label study consisting of two-parts: Part A Dose Escalation and Part B Dose Expansion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor (Phase I)
- What is being tested?
- BD200
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2026to 31 Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+ years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Participant willing to provide tumor biopsies
- Measurable disease per RECIST v1.1
- Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options
- Satisfy requirements for prior treatments per tumor type as outlined in the protocol
- Adequate organ function
- Agree to contraception requirements as outlined in the protocol
Who cannot join
- Any major surgery or traumatic injury prior to enrollment
- Unhealed wounds from surgery or injury
- Received other therapies within 4 weeks prior to enrollment
- Any clinically significant chronic gastrointestinal (GI) disorder
- Any clinically significant ascites or liver disease
- Any clinically significant pulmonary compromise
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- Active infection at the time enrollment
- Active autoimmune disease
- History or active skin disease requiring frequent treatment
- Any clinically significant corneal disorder
- Active known second malignancy
- Any clinically significant cardiac disease
- Participants with tumor abutting or eroding a major vessel
- Pregnant or lactating or planning to become pregnant
- Known hypersensitivity to BD200 or any of its ingredients
- Unresolved toxicities from previous anticancer therapy
- Participation in a concurrent clinical study in the treatment period
- Part A Only: Participant with hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV) infection
- Note: Other inclusion and exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1a/b, First-in-Human Dose Escalation and Dose Expansion Clinical Study of the Dual Targeting Trop-2 and Nectin-4 Multibody Drug Conjugate BD200 in Participants With Select Unresectable Locally Advanced or Metastatic Cancers
The Phase 1 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of BD200 in adult participants with advanced solid cancers. This is an open-label study consisting of two-parts: Part A Dose Escalation and Part B Dose Expansion. At least one tumor-specific cohort will be selected in Part B Dose Expansion.
- Conditions
- Solid Tumor (Phase I)
- Being tested
- BD200
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD200Drug
Infusion
BD200Drug
Infusion
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Escalation | Experimental | Participants with advanced or metastatic solid tumors will receive BD200. Receives: Drug: BD200 |
| Part B Dose Expansion | Experimental | Participants with at least one tumor type will receive BD200. Receives: Drug: BD200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Part A
Number of Participants with Dose Limiting Toxicities (DLTs)
Measured: Cycle 1 Day 1 through Cycle 1 Day 21 [approximately 21 days]
Phase 1 Part A & Part B
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation
Measured: Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [approximately 12 months]
Phase 1 Part A & Part B
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator
Measured: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
Phase 1 Part A & Part B
Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator
Measured: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months]
Secondary outcomes (8)
Phase 1 Part A & Part B
Area Under the Concentration Time Curve (AUC) of BD200
Measured: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
Phase 1 Part A & Part B
Maximum Observed Plasma Concentration (Cmax) of BD200
Measured: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
Phase 1 Part A & Part B
Number of Participants with Anti-drug Antibodies (ADAs) in Blood
Measured: Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months]
Phase 1 Part A
ORR per RECIST Version 1.1 as Assessed by Investigator
Measured: Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months]
Phase 1 Part A
DOR per RECIST Version 1.1 as Assessed by Investigator
Measured: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
Phase 1 Part B
IHC biopsy data of Trop-2 and Nectin 4 Expression
Measured: Cycle 1 Day 1 through EOT [up to approximately 12 months]
Phase 1 Part B
Progression Free Survival (PFS) per RECIST Version 1.1 as Assessed by Investigator
Measured: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
Phase 1 Part B
Overall Survival (OS)
Measured: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor (Phase I)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biolojic Design Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797907
- Sponsor's protocol ID
- BD200-101
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/b, First-in-Human Dose Escalation and Dose Expansion Clinical Study of the Dual Targeting Trop-2 and Nectin-4 Multibody Drug Conjugate BD200 in Participants With Select Unresectable Locally Advanced or Metastatic Cancers
- ClinicalTrials.gov ID
- NCT07797907
- Acronym / sponsor ID
- BD200-101
- Conditions
- Solid Tumor (Phase I)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Biolojic Design Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Phase 1 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of BD200 in adult participants with advanced solid cancers. This is an open-label study consisting of two-parts: Part A Dose Escalation and Part B Dose Expansion. At least one tumor-specific cohort will be selected in Part B Dose Expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A Dose Escalation | Experimental | Drug: BD200Participants with advanced or metastatic solid tumors will receive BD200. |
| Part B Dose Expansion | Experimental | Drug: BD200Participants with at least one tumor type will receive BD200. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18+ years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Participant willing to provide tumor biopsies
- Measurable disease per RECIST v1.1
- Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options
Key exclusion criteria (19 listed)
- Any major surgery or traumatic injury prior to enrollment
- Unhealed wounds from surgery or injury
- Received other therapies within 4 weeks prior to enrollment
- Any clinically significant chronic gastrointestinal (GI) disorder
- Any clinically significant ascites or liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BD200Infusion | Drug | Part A Dose Escalation |
| BD200Infusion | Drug | Part B Dose Expansion |
Primary outcome
Phase 1 Part A
Time frame: Cycle 1 Day 1 through Cycle 1 Day 21 [approximately 21 days]
Number of Participants with Dose Limiting Toxicities (DLTs)
Phase 1 Part A & Part B
Time frame: Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [approximately 12 months]
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation
Phase 1 Part A & Part B
Time frame: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator
Phase 1 Part A & Part B
Time frame: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months]
Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator
8 secondary outcomes
Phase 1 Part A & Part B
Time frame: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
Phase 1 Part A & Part B
Time frame: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
Phase 1 Part A & Part B
Time frame: Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months]
Phase 1 Part A
Time frame: Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months]
Phase 1 Part A
Time frame: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
Phase 1 Part B
Time frame: Cycle 1 Day 1 through EOT [up to approximately 12 months]
Phase 1 Part B
Time frame: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
Phase 1 Part B
Time frame: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BD200 in people with Solid Tumor (Phase I), run by Biolojic Design Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Biolojic Design, Ltd. (+972-8-6988048, contact@biolojic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Part A (time frame: Cycle 1 Day 1 through Cycle 1 Day 21 [approximately 21 days]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.