Authorised Phase I and Phase II (Integrated)- Other solid tumor

A Phase 1/2 Study of Inhaled KB707 in Patients

EU CTIS ID: 2025-522723-98-00

What this study is testing

To evaluate the safety and tolerability of inhaled KB707 monotherapy and in combination regimens (e.g., KB707 plus immune checkpoint inhibitors [with or without chemotherapy]; or docetaxel)

Phase I and Phase II (Integrated)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. The subject or legally authorized representative must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent Form and must be willing and able to comply with study procedures and instructions.
2. Age 18 years or older at the time of informed consent.
3. Life expectancy >12 weeks.
4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening
5. Have at least one measurable lung lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) at Screening.
6. Demonstrated adequate organ function at Screening, as defined below: a. WBC count ≥2000/μL (after at least 7 days without growth factor support) b. Absolute neutrophil count ≥1500/μL (after at least 7 days without growth factor support) c. Platelet count ≥100×103 μL d. Hemoglobin ≥9.0 g/dL e. Serum creatinine ≤2 mg/dL (or glomerular filtration rate ≥40 mL/min) f. AST and ALT ≤3x upper limit of normal (ULN)g. Total bilirubin within normal limits unless associated with hepatobiliary metastases or Gilbert’s syndrome, in that case total bilirubin ≤2x ULN

You likely can't join if

1. Not fully recovered from prior surgery or radiotherapy, including all radiation-related toxicities.
10. Subject has active, known, or suspected autoimmune disease requiring systemic treatment
11. Subject has known acute or chronic hepatitis.
12. Subject has active pneumonitis or history of ICI-induced pneumonitis that required steroids.
2. Have known medical history of positive test for, or diagnosis of, human immunodeficiency virus (HIV-1/2).
3. The subject is pregnant, nursing, or plans to become pregnant during study treatment and through three months after the last dose of KB707.

See the full eligibility criteria

Who can join

1. The subject or legally authorized representative must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent Form and must be willing and able to comply with study procedures and instructions.
2. Age 18 years or older at the time of informed consent.
3. Life expectancy >12 weeks.
4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening
5. Have at least one measurable lung lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) at Screening.
6. Demonstrated adequate organ function at Screening, as defined below: a. WBC count ≥2000/μL (after at least 7 days without growth factor support) b. Absolute neutrophil count ≥1500/μL (after at least 7 days without growth factor support) c. Platelet count ≥100×103 μL d. Hemoglobin ≥9.0 g/dL e. Serum creatinine ≤2 mg/dL (or glomerular filtration rate ≥40 mL/min) f. AST and ALT ≤3x upper limit of normal (ULN)g. Total bilirubin within normal limits unless associated with hepatobiliary metastases or Gilbert’s syndrome, in that case total bilirubin ≤2x ULN
7. Histologically confirmed diagnosis of advanced solid tumor malignancy affecting the lungs and the individual has progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or has no standard of care therapy.
8. Histologically or cytologically confirmed diagnosis of stage 3 or 4 NSCLC, as per American Joint Committee on Cancer (AJCC) staging system (8th edition)
9. Subject must meet the following criteria of prior lines of therapy: a. Subject has previously received no more than one line of prior immune checkpoint inhibitor (ICI) with or without platinum-based chemotherapy, or no more than two prior lines of therapy when given the ICI and platinum-based chemotherapy sequentially as two separate lines. b. Subjects with an actionable mutation (e.g., EGFR, KRAS, ALK, or ROS1 genomic alteration), are permitted to have received one additional line of approved targeted therapy.

What rules you out

1. Not fully recovered from prior surgery or radiotherapy, including all radiation-related toxicities.
10. Subject has active, known, or suspected autoimmune disease requiring systemic treatment
11. Subject has known acute or chronic hepatitis.
12. Subject has active pneumonitis or history of ICI-induced pneumonitis that required steroids.
2. Have known medical history of positive test for, or diagnosis of, human immunodeficiency virus (HIV-1/2).
3. The subject is pregnant, nursing, or plans to become pregnant during study treatment and through three months after the last dose of KB707.
4. Subject who is unwilling to comply with contraception requirements per-protocol.
5. Any clinical condition or clinically significant abnormality that, in the opinion of the Investigator, would impact a subject’s ability to complete all study-related procedures and/or poses an additional risk to the assessment of safety of KB707.
6. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator.
7. Subject has a known additional malignancy that is progressing or requires active treatment.
8. Subject has active brain metastases or leptomeningeal metastases.
9. Prior anti-PD-1/PD-L1 therapy was intolerable and required discontinuation of treatment.

The study team makes the final eligibility decision.

Where it's taking place

United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 2 diabetes Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.