KB707 for Advanced Cancer

Recruiting at 13 trial locations

Overseen By David Chien, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Krystal Biotech, Inc.

Must not be taking: Systemic corticosteroids

Disqualifiers: HIV, Active brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

240 Participants Needed

Trial Summary

What is the purpose of this trial?

KB707-01 is a Phase 1/2, open-label, multicenter, dose escalation and expansion study. The study will evaluate the safety and tolerability of KB707 in adults with locally advanced or metastatic solid tumors who have progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or for whom there is no standard of care therapy as well as the safety, tolerability, preliminary efficacy, and immunologic effect of KB707 administered in combination with Opdualag to subjects with unresectable or metastatic melanoma. Subjects in dose escalation (Cohorts 1 through 3) and dose expansion (Cohort 4) will receive intratumoral injections of KB707 approximately every three weeks. Cohorts 1 through 4 are closed to new enrollment. Dose expansion Cohort 5 and Cohort 6 will evaluate subjects with advanced melanoma. Subjects in Cohort 5 will receive intratumoral injections of KB707 biweekly (q2w), delivered in combination with Opdualag (dosed every q4w per prescribing information). Subjects in Cohort 6 will receive intratumoral injections of KB707 biweekly (q2w), delivered in combination with Keytruda (dosed every q6w per prescribing information). All subjects will be treated until disease progression, death, unacceptable toxicity, symptomatic deterioration, achievement of maximal response, subject choice, Investigator decision to discontinue treatment, or the Sponsor determines to terminate the study.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you must be fully recovered from prior surgery or radiation therapy and not require systemic corticosteroids. It's best to discuss your current medications with the trial team.

Research Team

David Chien, MD

Principal Investigator

Senior Vice President of Clinical Development

Eligibility Criteria

Adults with advanced or metastatic solid tumors who have not benefited from standard treatments, can't handle them, refused them, or have no available options. Participants must be over 18, have a tumor that can be injected through the skin and expected to live more than 12 weeks. They should also be relatively active and able to care for themselves (ECOG status of 0 or 1). Pregnant individuals or those on recent cancer therapies are excluded.

Inclusion Criteria

I have a tumor that can be measured and reached with a needle through the skin.

I am fully active or can carry out light work.

My advanced cancer has worsened despite treatment, or I can't undergo/decline standard treatments.

Exclusion Criteria

Pregnancy, nursing, or plans to become pregnant during study treatment and through three months after the last dose of KB707

I haven't had cancer treatment or been in a trial for at least 21 days or 5 half-lives of the treatment, whichever is shorter.

I have tested positive for HIV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Subjects receive intratumoral injections of KB707 approximately every three weeks in dose escalation cohorts

Varies until disease progression or other criteria

Every 3 weeks

Dose Expansion

Subjects receive intratumoral injections of KB707 in combination with Opdualag or Keytruda, biweekly

Varies until disease progression or other criteria

Biweekly (every 2 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 36 months

Treatment Details

Interventions

• KB707

Trial Overview The trial is testing KB707's safety and potential effectiveness when directly injected into tumors of patients with various types of advanced cancers like melanoma and carcinoma. It's an early-phase study where everyone gets the same experimental treatment without any comparison group.

Participant Groups

Group I: Dose expansion: KB707 in Combination with Opdualag (in patients with advanced melanoma) Experimental Treatment 2 Interventions

Dose expansion cohort: KB707 administered in combination with Opdualag in approximately 100 subjects with advanced melanoma.

Group II: Dose expansion: KB707 in Combination with Keytruda (in patients with advanced melanoma) Experimental Treatment 2 Interventions

Dose expansion cohort: KB707 administered in combination with Keytruda in approximately 100 subjects with advanced melanoma.

Group III: Dose escalation of KB707 by intratumoral (IT) injection in solid tumors Experimental Treatment 1 Intervention

Dose escalation of single-agent KB707 in 3 cohorts to treat superficial solid tumors

Who Is Running the Clinical Trial?

Krystal Biotech, Inc.

Lead Sponsor

Trials

15

Recruited

770+