This is an open label, multicenter, phase 1/1b study to assess safety/tolerability and
preliminary clinical activity of E7766 as a single agent administered intratumorally in
participants with advanced solid tumors or lymphomas.
The Phase 1/1b study consist of two parts: Dose Escalation and Dose Expansion. In the Dose
Escalation Part, E7766 will be administered intratumorally in participants with advanced
solid tumors or lymphomas to assess safety/tolerability profile of E7766 and to determine the
maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7766. In the Dose
Expansion Part, E7766 at RP2D will be administered to participants with melanoma, head and
neck squamous cell carcinoma (HNSCC), breast cancer, colorectal cancer, and/or other tumors
including lymphomas to confirm safety and assess preliminary clinical activity of E7766 as a
single agent. Clinical activity will be evaluated by objective response rate (ORR), duration
of response (DOR), and disease control rate (DCR) on treatment with E7766.
1. Participants with solid tumors or lymphomas, confirmed by available histopathology
records or current biopsy, that are advanced, nonresectable, or recurrent and
progressing since last antitumor therapy, and for which no alternative standard
2. Participants must have a minimum of one injectable lesion which is also accessible for
biopsy, and if available, one other measurable lesion also accessible for biopsy.
An injectable lesion is defined as being measureable (defined below) with a maximum of
3.0 centimeter (cm) longest diameter, accessible for injection as judged by the
investigator, and has not been subjected to any prior intratumoral treatment or
radiotherapy. Lesions selected for injection must not be too close to a major vessel
and not be associated with increased risk of bleeding, example, subcapsular liver
lesions or hypervascular tumors.
Measurable lesions are:
1. Solid tumors: At least 1 lesion of greater than or equal to (>=1) cm by longest
axial diameter or >=1.5 cm short axis diameter if a nodal lesion, which is
serially measurable according to modified Response evaluation criteria in solid
tumors (RECIST) 1.1 using CT/MRI or photography. Lesions that have had external
beam radiotherapy or locoregional therapies such as radiofrequency (RF) ablation
must show evidence of progression to be deemed a target lesion.
2. Lymphoma: At least 1 lymph node with a longest diameter greater than (>)1.5 cm or
an extranodal lesion with a longest diameter >1.0 cm
3. Participants with prior Hepatitis B or C are eligible if they have adequate liver
4. Adequate bone marrow function:
1. Absolute neutrophil count (ANC) >=1000 per cubic millimeter (/mm^3) (>=1.0*10^3
per microliter [/mcL])
2. Platelets >=75,000/mm^3 (>=75*10^ 9 per liter [/L])
3. Hemoglobin >=9.0 grams per deciliter (g/dL)
5. Adequate liver function defined by:
1. Adequate blood coagulation function as evidenced by an International Normalized
Ratio (INR) less than or equal to (<=)1.5
2. Total bilirubin <=1.5*upper limit of the normal range (ULN) except for
unconjugated hyperbilirubinemia or Gilbert's syndrome
3. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate
aminotransferase (AST) <=3*ULN (in the case of liver metastasis <=5*ULN) unless
there are bone metastases. Participants with ALP values >3*ULN and known to have
bone metastases can be included.
1. Other malignancy active within the previous 2 years except for basal or squamous cell
skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast
that has completed curative therapy.
2. Known human immunodeficiency virus (HIV) infection.
3. Major surgery within 4 weeks before the first dose of study drug.
4. Brain metastases that are untreated or in the posterior fossa or involve the meninges.
Participants with stable or progressing brain metastases (except in the posterior
fossa or involving the meninges) previously treated with brain stereotactic
radiotherapy (SRT), whole-brain radiotherapy (WBRT) and/or surgery are allowed as long
as the participant is asymptomatic neurologically and does not require immediate local
intervention (radiotherapy and/or surgery). In addition, participants must be off
immunosuppressive doses of systemic steroids (>10 milligram per day (mg/d) prednisone
or equivalent) for at least 4 weeks before study drug administration.
5. Prolongation of corrected QT (QTc) interval to >450 millisecond (msec) for males and
females when electrolytes balance is normal.
6. Females who are breastfeeding or pregnant at screening or baseline (as documented by a
positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin
[hCG]) test with a minimum sensitivity of 25 units per liter (IU/L) or equivalent
units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative
screening pregnancy test was obtained more than 72 hours before the first dose of
7. Females of childbearing potential must not have had unprotected sexual intercourse
within 30 days before study entry and must agree to use a highly effective method of
contraception (total abstinence [if it is their preferred and usual lifestyle], a
contraceptive implant, an oral contraceptive, or have a vasectomized partner with
confirmed azoospermia) throughout the entire study period and for 180 days after study
drug discontinuation. For sites outside of the European Union, it is permissible that
if a highly effective method of contraception is not appropriate or acceptable to the
participant, then the participant must agree to use a medically acceptable method of
contraception, that is, double barrier methods of contraception such as condom plus
diaphragm or cervical/vault cap with spermicide. If currently abstinent, the
participant must agree to use a highly effective method as described above if she
becomes sexually active during the study period or for 180 days after study drug
discontinuation. Females who are using hormonal contraceptives must have been on a
stable dose of the same hormonal contraceptive product for at least 28 days before
dosing and must continue to use the same contraceptive during the study and for 180
days after study drug discontinuation.
8. Male participants who are partners of women of childbearing potential must use a
condom and spermicide and their female partners if of childbearing potential must use
a highly effective method of contraception beginning at least 1 menstrual cycle prior
to starting study drug(s), throughout the entire study period, and for 180 days after
the last dose of study drug, unless the male participants are totally sexually
abstinent or have undergone a successful vasectomy with confirmed azoospermia or
unless the female partners have been sterilized surgically or are otherwise proven
sterile. No sperm donation is allowed during the study period or for 180 days after
study drug discontinuation.