No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
145 (estimated)
Sponsor
NextCure, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with advanced solid tumors such as ovarian, breast, or lung cancer. Participants will take LNCB74 to help researchers learn about its safety and the best dose.
Are You a Good Fit for This Trial?
Rules you outActive CNS metastasesCurrent pneumonitis or interstitial lung diseaseSevere sensory or motor neuropathyActive infection requiring systemic therapy
You may be able to join if
I am at least 18 years old.
I have advanced cancer that cannot be surgically removed.
I can provide a tissue sample from my tumor.
I am willing to undergo a new tumor biopsy if needed.
I have a performance status score of 0 or 1.
I expect to live for at least 12 more weeks.
I have measurable disease according to study guidelines.
I can give written consent to join the trial.
You may not be able to join if
I am pregnant or breastfeeding.
I have had treatment with chemotherapy or cancer therapy in the past month.
I have active infection needing treatment.
I have a known active infection with Hepatitis B or C.
I have a history of severe allergic reactions to LNCB74.
I have uncontrolled heart problems.
I have active or chronic eye disorders requiring treatment.
I have had major surgery in the past month.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and / or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
1. The participant provides written informed consent
2. ≥ 18 years of age on day of signing informed consent.
3. Participant with histologically or cytologically confirmed diagnosis of advanced unresectable and/or metastatic solid tumors
4. A male participant must agree to use c…
Inclusion Criteria:
1. The participant provides written informed consent
2. ≥ 18 years of age on day of signing informed consent.
3. Participant with histologically or cytologically confirmed diagnosis of advanced unresectable and/or metastatic solid tumors
4. A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child
5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential
6. Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
7. Able to provide tumor tissue sample.
8. Willing to undergo fresh tumor biopsy at Screening and On-treatment if archival tissue not available
9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
10. Life expectancy greater than or equal to 12 weeks as judged by the Investigator.
11. Have adequate organ function
Exclusion Criteria:
1. A WOCBP who has a positive serum pregnancy test (within 72 hours) prior to treatment.
2. Has received prior investigational agents within 4 weeks prior to treatment.
3. Has received anti-cancer chemotherapy (Immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy within 2 weeks prior to treatment.
4. Has received antibody-based anti-cancer therapy within 4 weeks prior to treatment.
5. Has received targeted agents and small molecules within 2 weeks or 5 half-lives, whichever is longer.
6. Has received prior platinum-based chemotherapy and progressed within 4 weeks of initiating therapy (platinum-refractory disease)
7. Has received an ADC with MMAE payload.
8. Has received prior radiotherapy within 2 weeks of start of study treatment for focal radiation or within 4 weeks for wide-field radiotherapy
9. Has received G-CSF or GM-CSF within 7 days prior to start of study treatment.
10. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
11. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
12. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
13. Has known active CNS metastases and/or carcinomatous meningitis
14. Has severe hypersensitivity (≥ Grade 3), known allergy or reaction LNCB74 or any of its excipients.
15. Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
16. Has active ≥Grade 2 sensory or motor neuropathy.
17. Has active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy or any clinically significant corneal disease.
18. Has an active infection requiring systemic therapy.
19. Any major surgery within 4 weeks of study drug administration.
20. Toxicity (except for alopecia) related to prior anti-cancer therapy and/or surgery, unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.
21. Prior organ or tissue allograft.
22. Uncontrolled or significant cardiovascular disease
23. Participants with serious or uncontrolled medical disorders.
24. Participants who are on total parenteral nutrition (TPN)
25. Participants with history of bowel obstruction within one month of screening
26. Participants with history of significant ascites requiring paracentesis within 2 weeks of screening
27. Has a known history of human immunodeficiency virus (HIV) infection with an acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within the last year, or a current CD4 count \<350 cells/µl
28. Has known active Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection
29. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study
30. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Contacts
No contact information available.
What are you hoping to find?
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.